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Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery

NCT04291508 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2024-09-27

Study results available
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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.

Conditions

Interventions

DRUG

Intravenous Acetaminophen (room temperature)

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)

DRUG

Intravenous Vitamin C (refrigerated)

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

DRUG

5% Dextrose (room temperature)

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

DRUG

5% Dextrose refrigerated

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Boyd Taylor Thompson, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2023-04-27
Completion
2023-07-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291508 on ClinicalTrials.gov