Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Health-Related Quality of Life in Sepsis.
Anne V Grossestreuer, Ari Moskowitz, Lars W Andersen...
https://pubmed.ncbi.nlm.nih.gov/33251516Actively Recruiting
Led by Beth Israel Deaconess Medical Center · Updated on 2026-02-18
86
Participants Needed
1
Research Sites
12 weeks
Total Duration
Researchers are evaluating whether a short course of intravenous hydrocortisone, an anti-inflammatory medication, can improve clinical outcomes and reduce hospital stay length in patients with severe acute pancreatitis. This randomized, double-blind, placebo-controlled study focuses on patients admitted to intensive care with significant disease severity, aiming to see if reducing inflammation can slow disease progression. Participants receive either hydrocortisone (100 mg in 50 milliliters of saline) or a placebo (50 ml of saline) administered intravenously every 8 hours for 72 hours, totaling nine doses. Nursing staff deliver the treatments following standard clinical procedures. The study uses a quadruple-blind design where patients, caregivers, investigators, and outcomes assessors do not know the assigned treatment. Throughout the study, researchers assess the Sequential Organ Failure Assessment (SOFA) score to monitor changes in illness severity. Blood samples are taken at multiple time points to measure biomarkers. Secondary outcomes include respiratory failure, ventilator-free days, mortality rates up to 90 days, hospital-free days, and long-term quality of life measures. The total participation includes up to 90 days of follow-up to evaluate these outcomes and safety.
CONDITIONS
Corticosteroids to Treat Pancreatitis
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 72 hours
Participants receive intravenous hydrocortisone or placebo every 8 hours for 72 hours as per standard clinical procedures by nursing staff.
Approximately 9 administrations over 3 days
Duration - Up to 90 days
Participants are monitored for clinical outcomes, including respiratory function, survival, and quality of life up to 90 days after enrollment.
Visits as per clinical schedule up to 90 days
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
M
Michael Donnino, MD
K
Katherine Berg, MD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Anne V Grossestreuer, Ari Moskowitz, Lars W Andersen...
https://pubmed.ncbi.nlm.nih.gov/33251516Ari Moskowitz, David T Huang, Peter C Hou...
https://pubmed.ncbi.nlm.nih.gov/32809003Michael W Donnino, Lars W Andersen, Katherine M Berg...
https://pubmed.ncbi.nlm.nih.gov/27038920Jacob Vine, Noa Berlin, Ari Moskowitz...
https://pubmed.ncbi.nlm.nih.gov/38431131