European Journal of Cardiovascular Medicine

Critically ill (CI) patients, particularly those suffering from multi-organ dysfunction or sepsis, face a significantly increased risk of morbidity and mortality, necessitating timely identification and intervention to improve clinical outcomes [1,2]. Sepsis, defined as a dysregulated host response to infection leading to life-threatening organ dysfunction, remains a major contributor to ICU admissions and in-hospital mortality, especially in low- and middle-income countries (LMICs) like India [3]. Despite its widespread burden, data regarding the epidemiology of sepsis in India are limited. A comprehensive multi-center study across 135 Indian ICUs found a sepsis prevalence of 46.2% (Sepsis-2) and 33.2% (Sepsis-3), with an overall mortality rate of 27.6% [4].

Prognostic tools such as the Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) have been developed to assist clinicians in risk stratification and therapeutic decision-making [1]. The SOFA score, in particular, is widely accepted for quantifying organ dysfunction across six systems—respiratory, cardiovascular, hepatic, coagulation, renal, and neurological—offering scores ranging from 0 to 24. A score ≥2, especially in the presence of infection, is indicative of sepsis and is associated with increased mortality risk [5–7].

In parallel with scoring systems, biomarkers have emerged as valuable tools for early risk assessment. Among these, serum albumin has gained clinical relevance due to its accessibility, affordability, and correlation with systemic illness severity. As the most abundant plasma protein (comprising 50–60% of total protein), albumin contributes to oncotic pressure and exhibits antioxidant, anti-inflammatory, and endothelial-protective properties [1,2]. In critical illness, serum albumin levels typically decline rapidly due to inflammation-induced capillary leak, reduced hepatic synthesis, and redistribution, and remain low until recovery is underway. Hypoalbuminemia has been consistently associated with prolonged ICU stays, increased complication rates, and higher mortality [8,9].

In resource-limited settings like India, where ICU capacities are often strained, serum albumin offers a practical biomarker for early prognostication and triage [1,10]. Although SOFA and APACHE II scores provide robust mortality prediction, their accuracy may be enhanced by integrating serial biomarker data, notably serum albumin [11,12].

This study aimed to assess the prognostic value of serial serum albumin levels in critically ill patients alongside SOFA scores. Specifically, it sought to (1) evaluate SOFA scores upon ICU admission, (2) monitor serum albumin on Days 0, 3, and 5, and classify patients based on albumin levels, and (3) correlate these with outcomes such as survival and ICU stay duration, thereby enhancing risk stratification and guiding individualized care.

This prospective observational study was conducted in the Intensive Care Unit (ICU) of Sri Aurobindo Medical College and Postgraduate Institute (SAIMS), Indore, over a period of 12 months. The study population comprised adult critically ill patients admitted to the ICU during the study period who met the predefined inclusion criteria. Ethical clearance was obtained from the Institutional Ethics Committee, and informed written consent was taken from patients or their legally authorized representatives prior to inclusion.

Sample Size: Considering the average number of critically ill admissions in the ICU and feasibility of serial testing, a total sample size of 100 patients was determined to be adequate for the study. All eligible patients admitted during the study period were consecutively enrolled until the target sample size was achieved.

Inclusion Criteria

• Adult patients (age ≥18 years) admitted to the ICU with critical illness
• Willingness to participate in the study, with informed consent provided by patient or next of kin

Exclusion Criteria

• Patients were excluded if they had pre-existing chronic conditions known to cause hypoalbuminemia, including:
• Chronic liver disease
• Nephrotic syndrome
• Protein-losing enteropathy
• Chronic malnutrition
• Chronic kidney disease
• Patient refusal to participate in the study

METHODOLOGY

Upon ICU admission, patients were assessed for eligibility based on clinical criteria and the Sequential Organ Failure Assessment (SOFA) score. The SOFA score was calculated to assess the extent of organ dysfunction. It incorporates six physiological systems—respiratory, cardiovascular, hepatic, coagulation, renal, and neurological—each scored from 0 (normal function) to 4 (severe dysfunction), yielding a total score ranging from 0 to 24. A higher SOFA score correlates with increased severity of illness and risk of mortality.

All enrolled patients underwent a comprehensive clinical evaluation, including detailed history-taking and systemic examination. Baseline investigations were conducted as per ICU protocol. Serum albumin levels and SOFA scores were measured serially on Day 0 (admission), Day 3, and Day 5. Based on serum albumin values, patients were stratified into three groups: a high albumin group (albumin >3.5 g/dL), normal albumin group (3.5-2.0) and a low albumin group (albumin <2.0 g/dL). Patients were followed prospectively to monitor clinical progression, complications, duration of ICU stay, and outcome status (survived or deceased). The correlation between SOFA scores, serum albumin levels, and clinical outcomes was evaluated to determine the prognostic value of these parameters in critically ill patients.

All participants underwent standardized laboratory investigations, including complete blood count (CBC), fasting and postprandial blood sugar (FBS, PPBS), liver function tests (serum bilirubin, SGOT, SGPT), renal function tests (urea, creatinine), serum electrolytes, arterial blood gas (ABG) analysis, and serial serum albumin measurements. Additionally, imaging and cardiac assessments were performed using electrocardiography (ECG), ultrasonography of the whole abdomen, and 2D echocardiography.

Relevant data, including demographics, clinical findings, laboratory values, SOFA scores, and outcomes, were recorded using a structured proforma. Laboratory results were transcribed directly from institutional records to ensure accuracy.

Statistical Analysis

Data were entered in Microsoft Excel 2010 and analyzed using R software. Descriptive statistics were presented as mean ± standard deviation for continuous variables and as frequencies and percentages for categorical variables. Comparative analysis across groups was performed using one-way ANOVA or Kruskal-Wallis tests, with appropriate post-hoc analyses. For within-patient comparisons over time, repeated measures ANOVA or the Friedman test was applied. A p-value of <0.05 was considered statistically significant for all inferential analyses.

The study included 100 critically ill ICU patients, of whom 57% were male and 43% female. The overall survival rate was 74%, while the mortality rate was 26%. Survivors tended to be younger (mean age 67.2 years) compared to non-survivors (mean age 71.8 years), and this difference was statistically significant (p<0.001), indicating age as an important prognostic factor.

No significant differences were observed between survivors and non-survivors regarding the prevalence of hypertension, diabetes mellitus or cardiac disease. However, the presence of chronic pulmonary disease and malignancy was significantly associated with increased mortality (p=0.005 and 0.007, respectively), suggesting that these comorbidities adversely influence outcomes in critically ill patients.

Pulmonary infections were the most common source of sepsis and were significantly more prevalent in non-survivors (46.1%) compared to survivors (28.4%) (p<0.001). Other sources such as genitourinary and gastrointestinal infections showed varied associations, with genitourinary infections being more common in survivors and gastrointestinal infections more frequent among non-survivors.

Vital sign analysis revealed that non-survivors had a significantly higher respiratory rate and heart rate at presentation (p<0.001 and p=0.002, respectively), indicating a higher physiological stress response. Additionally, non-survivors had significantly lower systolic blood pressure on admission (p=0.045), which may reflect early hemodynamic compromise.

Importantly, the initial SOFA score was significantly higher in non-survivors (8.1 ± 3.3) compared to survivors (5.8 ± 2.9) (p<0.001), affirming its strong prognostic value in predicting mortality. This underscores the clinical utility of SOFA scoring in early risk stratification and guiding intensive care management. [Table 1]

Table 1. Baseline and Clinical Characteristics of the Study Population (n = 100)

The laboratory profile of the study cohort (n = 100) revealed several statistically significant differences between survivors (n = 74) and non-survivors (n = 26), underscoring the clinical relevance of routine biochemical and hematological markers in prognosticating sepsis outcomes. Non-survivors of sepsis exhibited a significantly deranged laboratory profile compared to survivors, with elevated total leukocyte counts (14.6 ± 27.9 × 10³/μL vs. 12.1 ± 13.0 × 10³/μL; p = 0.015) and lower platelet counts (151 ± 129 × 10³/μL vs. 165 ± 120 × 10³/μL; p < 0.001), reflecting heightened inflammation and possible consumptive coagulopathy. Hemoglobin and hematocrit were significantly lower (p < 0.001), indicating more severe anemia. Renal dysfunction was pronounced in non-survivors, with higher blood urea nitrogen (44 ± 25 mg/dL vs. 32 ± 21 mg/dL; p < 0.001) and creatinine (2.3 ± 1.8 mg/dL vs. 1.8 ± 1.6 mg/dL; p < 0.001). Hypoalbuminemia was more severe (2.6 ± 0.6 g/dL vs. 3.1 ± 0.6 g/dL; p < 0.001), highlighting its prognostic importance. Liver enzymes, especially AST (185 ± 590 IU/L vs. 118 ± 460 IU/L; p < 0.001), were elevated, suggesting hepatocellular injury. Coagulation was more impaired in non-survivors (INR: 1.6 ± 1.1 vs. 1.4 ± 0.8; p < 0.001), and inflammatory marker CRP was higher (18.2 ± 14.9 mg/dL vs. 15.0 ± 12.6 mg/dL; p < 0.001). Lactate levels were markedly increased (6.2 ± 4.0 mmol/L vs. 3.7 ± 2.6 mmol/L; p < 0.001), indicating severe tissue hypoperfusion. Acidosis was evidenced by lower arterial pH (7.36 ± 0.15 vs. 7.42 ± 0.09; p < 0.001) and bicarbonate (17.1 ± 6.5 mmol/L vs. 18.9 ± 6.1 mmol/L; p < 0.001). Respiratory parameters, including PaCO₂ (30.5 ± 13.8 mmHg vs. 29.0 ± 11.2 mmHg; p < 0.001) and PaO₂ (94.6 ± 55.3 mmHg vs. 90.1 ± 41.3 mmHg; p = 0.004), were also significantly altered. These statistically significant differences confirm that elevated lactate, hypoalbuminemia, renal and hepatic dysfunction, and acidosis are strong predictors of mortality in sepsis.

Table 2. Laboratory Findings of the Study Population (n = 100)

Table 3 presents the distribution of clinical and laboratory variables across different serum albumin level strata in critically ill patients. A consistent trend was observed wherein decreasing albumin levels were associated with worsening clinical parameters and higher mortality rates. Patients with lower albumin levels (<2.5 g/dL) exhibited a higher prevalence of comorbidities such as malignancy, chronic renal disease, and liver cirrhosis compared to those with higher albumin levels (>3.0 g/dL). Conversely, cardiac comorbidities were more commonly seen in patients with relatively preserved albumin levels. A progressive decline in hemoglobin and platelet counts was noted with decreasing albumin, indicating a correlation with systemic inflammation or chronic disease burden. Furthermore, as albumin levels dropped, there was a corresponding rise in blood urea nitrogen, serum creatinine, and initial lactate levels, reflecting deteriorating renal function and impaired tissue perfusion.

Table 3. Clinical and Laboratory Characteristics According to Albumin Levels (n = 100)

The analysis of mean SOFA scores across serum albumin groups on Days 0, 3, and 5 revealed a significant inverse correlation between serum albumin levels and organ dysfunction severity. On Day 0, patients with albumin >3.5 g/dL had the lowest mean SOFA score (5.2 ± 1.6), followed by the 3.5–2.0 g/dL group (7.8 ± 2.2), and the <2.0 g/dL group (9.4 ± 2.8). This trend persisted and intensified over time, with SOFA scores on Day 5 recorded at 4.9 ± 1.3, 8.1 ± 1.9, and 10.1 ± 2.6 for the respective groups. The progressively increasing SOFA scores in patients with lower albumin levels reflect worsening multi-organ dysfunction and poorer clinical status. Notably, patients with albumin <2.0 g/dL consistently had the highest SOFA scores across all days, highlighting the prognostic significance of hypoalbuminemia. These findings suggest a strong inverse association between serum albumin and SOFA scores, reinforcing the role of albumin as a dynamic and reliable marker of illness severity in critically ill patients. [Table 4]

Table 4: Serum Albumin Levels, Mortality, and SOFA Scores on Day 0, Day 3, and Day 5

Figure 2. Mean SOFA Score Across Serum Albumin Groups by Day

The multivariate logistic regression analysis across Day 0, Day 3, and Day 5 identified several key independent predictors of mortality in septic shock patients, with strong statistical significance. On Day 0, advanced age (OR: 1.022; 95% CI: 1.016–1.028; p < 0.001), elevated initial lactate levels (OR: 1.185; 95% CI: 1.162–1.209; p < 0.001), and a higher SOFA + albumin composite score (OR: 1.149; 95% CI: 1.121–1.178; p < 0.001) were all significantly associated with increased mortality risk.

By Day 3, persistently low albumin levels and rising composite SOFA + albumin scores continued to demonstrate predictive strength. The OR for persistent hypoalbuminemia was 1.207 (95% CI: 1.154–1.263; p < 0.001), while an elevated SOFA + albumin score had an OR of 1.164 (95% CI: 1.132–1.196; p < 0.001), indicating worsening organ dysfunction and nutritional depletion as critical drivers of mortality.

On Day 5, patients with a SOFA + albumin score ≥21 had a markedly increased risk of death (OR: 1.295; 95% CI: 1.182–1.419; p < 0.001), and those with serum albumin levels <2.0 g/dL had a significant association with mortality (OR: 1.214; 95% CI: 1.140–1.293; p < 0.001). These findings confirm that the integration of dynamic organ dysfunction (SOFA) with nutritional status (albumin) offers a robust and consistent method for risk stratification and early identification of critically ill septic patients at high risk of poor outcomes.

Independent Predictors of Day 0, 3, and 5 Mortality in Septic Shock Patients

The SOFA + albumin composite score demonstrated consistently superior performance in predicting mortality among septic shock patients across all three time points. On Day 0, the SOFA + albumin model showed the highest discriminative ability with an AUC of 0.714 (95% CI: 0.702–0.726; p < 0.001), outperforming both SOFA alone (AUC: 0.681) and SOFA + lactate (AUC: 0.682). The model also exhibited excellent calibration with an R² of 0.991, compared to 0.889 for SOFA alone. By Day 3, the predictive accuracy of the SOFA + albumin model remained strong, with an AUC of 0.726 (95% CI: 0.711–0.741; p < 0.001), again higher than SOFA alone (AUC: 0.692) and SOFA + lactate (AUC: 0.693). Calibration improved further with an R² of 0.993. On Day 5, the model maintained its lead with an AUC of 0.738 (95% CI: 0.722–0.754; p < 0.001), compared to SOFA alone (AUC: 0.701) and SOFA + lactate (AUC: 0.699). The calibration was excellent, with an R² of 0.995, indicating near-perfect predictive consistency.

Kaplan–Meier survival analysis further validated these findings, showing that patients with SOFA + albumin scores <7 had the highest survival, those with scores 10–13 had intermediate survival, and patients with scores ≥21 had very poor survival (>90% mortality). These results confirm that the SOFA + albumin combination not only enhances prognostic accuracy but also allows meaningful stratification of critically ill patients throughout the course of ICU management.

Figure 2. ROC Curve Comparison for Day 0, Day 3, and Day 5 for Mortality Prediction

Table 5. Mortality Rate According to SOFA + Albumin Score (Day 0, Day 3, Day 5)

Figure 3. Mortality According to SOFA + Albumin Score (Day 0, 3, 5)

This prospective observational study assessed the prognostic value of serial serum albumin levels in critically ill ICU patients and their integration with the SOFA score. The results demonstrated that persistent or progressive hypoalbuminemia is significantly associated with increased organ dysfunction and higher mortality. The study found a 26% ICU mortality rate, with non-survivors being older (mean age 71.8 vs. 67.2 years; p < 0.001). While common comorbidities like hypertension and diabetes did not affect survival, chronic pulmonary disease and malignancy were linked to higher mortality—consistent with findings by Kim C et al. [12].

Baseline health status was also found to influence outcomes, with age and comorbidities contributing notably to mortality risk, as supported by Garland et al. [13] and others. Non-survivors had significantly higher heart and respiratory rates, lower systolic BP, and elevated initial SOFA scores (8.1 vs. 5.8; p < 0.001), confirming SOFA's predictive utility. These findings align with previous studies and meta-analyses, including those by Raith et al. [14] and Kim et al. [12], which established a strong association between higher SOFA scores and mortality in septic patients.

Serum albumin, traditionally a marker of nutritional status, is increasingly recognized as a dynamic indicator of illness severity and systemic inflammation in critically ill patients. This study found that patients with low serum albumin levels (<2.5 g/dL), especially those below 2.0 g/dL, had significantly higher mortality and SOFA scores throughout their ICU stay, with mortality exceeding 70% by Day 5 in the lowest albumin group. These findings support the role of hypoalbuminemia as a reflection of not only malnutrition but also systemic inflammation, capillary leakage, and organ failure.

The results are consistent with Kim et al. [12], who observed that for every 0.5 g/dL drop in albumin, mortality rose by approximately 10%. Albumin plays crucial roles in maintaining oncotic pressure and exhibiting anti-inflammatory and antioxidant functions. Critical illness impairs albumin synthesis and promotes its redistribution and degradation, leading to hypoalbuminemia. Studies have linked low albumin to worse outcomes in sepsis, and this study supports those findings by demonstrating a strong association between hypoalbuminemia and poor outcomes, including in patients with chronic illnesses and frailty. [15,16]

In this cohort, non-survivors had significantly lower initial albumin levels (2.6 ± 0.6 g/dL vs. 3.1 ± 0.6 g/dL; p < 0.001). This finding supports observations by Pal A et al. [2], who noted a marginally lower day 1 SA in non-survivors (3.06 ± 0.54 g/dL) versus survivors (3.21 ± 0.60 g/dL), though not statistically significant. Similarly, Nirmala et al. [17] reported a comparable trend (3.44 ± 0.30 vs. 3.46 ± 0.25 g/dL). However, while prior studies suggested non-significant differences at baseline, our results showed a highly significant early divergence, indicating that even initial hypoalbuminemia may serve as a critical red flag in high-risk ICU populations.

Serial declines in albumin were also linked to worsening biochemical parameters, such as elevated BUN, creatinine, lactate, and AST, alongside acidosis and anemia. The albumin trend over time was distinctly different between survivors and non-survivors, reinforcing the prognostic value of serial measurement. More importantly, the serial trend of serum albumin in our cohort showed a progressive decline among non-survivors and a gradual recovery among survivors. These temporal patterns mirror those reported by Pal A et al. [2], who documented a consistent rise in SA from day 3 onward in survivors, reaching a significantly higher level by day 5 (3.43 ± 0.64 g/dL), while non-survivors showed a continuous decline until day 4 with only a minimal and inconsistent rise by day 5 (2.46 ± 0.52 g/dL). In our study, patients with albumin levels <2.0 g/dL had mortality exceeding 70%, while those with levels >3.5 g/dL had the lowest mortality, reinforcing Pal’s observation that an SA threshold of 2.5 g/dL on day 5 is a strong predictor of poor outcomes.

Our results also align with Mahajan et al. [18], who emphasized day 3 serum albumin as the strongest predictor of ICU mortality (3.04 ± 0.51 g/dL in survivors vs. 2.75 ± 0.22 g/dL in non-survivors). Likewise, Nirmala et al. [17] showed that SA on day 3 (2.83 ± 0.51 in non-survivors) was significantly associated with mortality. A study done by Gosavi S et.al also shows the mean Serum albumin on day of admission in survivors and non-survivors was 3.06 gm% (+/-0.54) and 2.45 gm% (+/-0.50) (p< 0.01). [19] These findings reinforce the prognostic value of mid-course SA measurement, particularly around day 3, as an actionable marker in ICU management.

The study also found that combining albumin with the SOFA score improved predictive accuracy (AUC 0.71 vs. 0.68 for SOFA alone), suggesting that integrating nutritional/inflammatory markers with organ dysfunction scores offers a better mortality prediction tool in sepsis. These results support the development of combined scoring models to refine risk stratification in ICU patients and highlight the potential of albumin as both a prognostic biomarker and a target for future interventions.

This study demonstrated that combining the SOFA score with serum albumin significantly enhances prognostic accuracy in critically ill patients. The SOFA + albumin composite model showed superior discriminatory power (AUC 0.714 on Day 0, increasing to 0.738 by Day 5) compared to SOFA alone or SOFA + lactate. Calibration was excellent (R² > 0.99), indicating a reliable and consistent model for mortality prediction.

Multivariate logistic regression confirmed that serum albumin is an independent predictor of mortality, alongside age and lactate levels. These findings align with prior studies by Kim et al. [12], Vincent et al. [20] and Lee et al. [21], which also identified low albumin as a strong predictor of ICU mortality when considered with dynamic clinical parameters. Kaplan–Meier survival analysis supported this, revealing that patients with SOFA + albumin scores ≥21 had dramatically lower survival, reinforcing the composite score’s clinical utility in risk stratification and prognosis discussions.

In terms of morbidity, persistently low albumin levels were associated with prolonged ICU stay and higher SOFA scores, confirming findings by Pal A et al. [2], who observed that a steep fall and delayed recovery of albumin correlated with longer hospital stays (>7 days). Similarly, Gosavi S et al. reported significantly lower SA levels in patients with prolonged ICU stays and complications (>21 days), underlining hypoalbuminemia’s role in extended morbidity. [19]

No significant relationship was found between initial SA and ventilator requirement in this study, which agrees with Pal A et al., but contrasts with Santosh et al., who observed lower albumin levels in patients requiring mechanical ventilation. These mixed results indicate the need for further research. [2,19]

Finally, consistent with Blunt et al., our study observed that patients who recovered to albumin levels >3.0 g/dL had better outcomes, suggesting that the ability to restore SA may serve as a biomarker for resilience and recovery capacity. [2] The study confirms the value of integrating serial albumin with SOFA scoring to improve early prognostication and guide ICU care.

In summary, the study confirms that serial serum albumin is a robust, inexpensive, and dynamic biomarker that can reliably predict mortality and correlate with organ dysfunction in critically ill patients. Its prognostic value is further enhanced when integrated with the SOFA score, offering a powerful tool for early risk stratification and ongoing clinical assessment. Future research should aim to validate these findings in multicentric cohorts and assess the potential benefits of albumin supplementation in select subgroups with severe hypoalbuminemia.

This study confirms that serial monitoring of serum albumin levels, when used in combination with the SOFA score, offers significant prognostic value in critically ill patients, particularly those with sepsis or septic shock. The SOFA + albumin composite score consistently outperformed conventional scoring systems in predicting mortality and identifying high-risk patients at all three time points (Day 0, 3, and 5). Key findings such as advanced age, elevated lactate, persistent hypoalbuminemia, and a composite score ≥21 emerged as independent and robust predictors of mortality. The integration of albumin into prognostic frameworks not only enhances early risk detection but also offers a cost-effective, widely available biomarker in resource-constrained settings. Given the rising burden of critically ill patients including sepsis in India and globally, this combined approach can support timely, individualized ICU interventions, optimize resource allocation, and ultimately improve patient outcomes. Further large-scale, multicenter validation is warranted to standardize its clinical adoption.

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