CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 488 enrolled
Drug / intervention
Intravenous Acetaminophen (room temperature) +3 moredrug
Likely dose
Intravenous Acetaminophen (room temperature) 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04291508
NCT04291508Phase 2Completed
CompareCT.gov

Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery

Massachusetts General Hospital·interventional·Posted Mar 2, 2020·Updated Sep 27, 2024

In Brief

A Phase 2 clinical trial evaluating Intravenous Acetaminophen (room temperature), Intravenous Vitamin C (refrigerated), and 2 other interventions for Acute Respiratory Distress Syndrome and 3 related conditions. Completed, enrolled 488 participants across 41 sites.

Detailed Summary

Prospective multi-center phase 2b randomized placebo-controlled double-blinded interventional platform trial of two different pharmacologic therapies (intravenous Vitamin C or intravenous Acetaminophen) for patients with sepsis-induced hypotension or respiratory failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Respiratory Distress Syndrome, Critical Illness, Respiratory Failure, Sepsis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 2, 2020
Enrollment StartOct 13, 2021
Primary CompletionApr 27, 2023
Study CompletionJul 27, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.3 years ago

Interventions

Intravenous Acetaminophen (room temperature)drug

Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs \< 50 kg) every six hours for 5 days (20 doses)

Intravenous Vitamin C (refrigerated)drug

Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses)

5% Dextrose (room temperature)drug

Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses)

5% Dextrose refrigerateddrug

Placebo (identical appearing refrigerated 5% dextrose solution) infused every six hours for 5 days (20 doses)