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Ulinastatin Add-on to Standard of Care in Critically Ill COVID-19 Patients: A Multicenter, Retrospective Study
Yatin Mehta1, Kapil Zirpe2, Subhal Dixit3
1Director, Department of Critical Care Medicine, Medanta Institute of Critical Care and Anaesthesiology, Medanta, The Medicity, Gurugram, Haryana.
Insights
Ulinastatin (ULI) as add-on therapy may reduce 30-day mortality in intensive care unit (ICU) patients with coronavirus disease (COVID-19), particularly those not requiring intubation. Further randomized studies are needed to confirm these findings for COVID-19 treatment.
Area of Science:
- Critical Care Medicine
- Pharmacology
- Infectious Diseases
Background:
- Coronavirus disease (COVID-19) poses significant challenges in intensive care units (ICUs).
- Limited therapeutic options exist for severe COVID-19 cases requiring ICU admission.
- Ulinastatin (ULI) is a protease inhibitor with potential anti-inflammatory properties.
Purpose of the Study:
- To evaluate the impact of ulinastatin (ULI) as an add-on therapy to standard of care (SOC) on 30-day mortality in ICU patients with COVID-19.
- To compare outcomes between patients receiving SOC alone versus ULI plus SOC.
Main Methods:
- A multicentric, retrospective study involving 94 COVID-19 patients admitted to the ICU.
- Comparison of 30-day mortality between patients treated with SOC alone and those receiving ULI as add-on to SOC.
- Odds ratios (OR) and 95% confidence intervals (CI) were calculated to identify mortality predictors.
Main Results:
- Univariate analysis showed significantly lower 30-day mortality in the ULI plus SOC group (36.2%) compared to SOC alone (51.1%).
- The beneficial effect of ULI was more pronounced in non-intubated patients and with early ULI administration (within 72 hours).
- Multivariate analysis indicated intubation as the sole predictor of mortality, with ULI's effect on survival becoming non-significant.
Conclusions:
- Early administration of ulinastatin (ULI) may improve outcomes in COVID-19 ICU patients, especially those not requiring intubation.
- The findings suggest ULI could be a potentially helpful therapeutic option given limited treatment choices.
- A large, randomized controlled trial is recommended to validate these preliminary findings and confirm ULI's efficacy in COVID-19 patients.
Aim:
To assess the impact on 30-day mortality with ulinastatin (ULI) used as add-on to standard of care (SOC) compared to SOC alone in coronavirus disease (COVID-19) patients requiring admission to the intensive care unit (ICU).
Materials And Methods:
In this multicentric, retrospective study, we collected data on clinical, laboratory, and outcome parameters in patients with COVID-19. Thirty-day mortality outcome was compared among patients treated with SOC alone and ULI used as add-on to SOC. Odds ratio (OR) and 95% confidence intervals (CI) were determined to identify the predictors of 30-day mortality.
Results:
Ninety-four patients were identified and enrolled in both groups with comparable baseline parameters. On univariate analysis, 30-day mortality was significantly lower in ULI plus SOC group than SOC alone group (36.2 vs 51.1%, OR 0.54, 95% CI 0.30-0.97, p = 0.040). The effect on mortality was more pronounced in patients who did not require intubation (10.9 vs 34.0%, OR 0.24, 95% CI 0.09-0.66, p = 0.006) and with early administration (within 72 hours of admission) of ULI (30.7 vs 57.9%, OR 0.32, 95% CI 0.11-0.91, p = 0.032). On multivariate analysis, only intubation predicted mortality (adjusted OR 10.13, 95% CI 3.77-27.25, p<0.0001) and the effect of ULI on survival was not significant (adjusted OR 0.58, 95% CI 0.22-1.52, p = 0.270).
Conclusion:
Given the limited options for COVID-19 patients treated in ICU, early administration of ULI may be helpful, especially in patients not requiring intubation to improve the outcomes. Further, a large, randomized study is warranted to confirm these findings.
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