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NCT04291508 · ClinicalTrials.gov registry record · Phase 2

Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery

A Phase 2 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 2
Development phase
488
Enrollment target

NCT04291508: Completed Phase 2 study, sponsored by Massachusetts General Hospital.

NCT04291508 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 488 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (267% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT04291508, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 2
Development phase
488 participants
Enrollment target

Study 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.

Primary Outcome

Defined as the days alive and free of organ support (dialysis, assisted ventilation, and vasopressors) to day 28. Participants will need to be free of all three components (assisted ventilation, vasopressors, new renal replacement therapy) to qualify for a day alive and free from organ failures. Patients on chronic dialysis will not be scored for the new renal failure free component of this outcome.

Interventions

  • DRUG Intravenous Acetaminophen (room temperature)
  • DRUG Intravenous Vitamin C (refrigerated)
  • DRUG 5% Dextrose (room temperature)
  • DRUG 5% Dextrose refrigerated

Trial Details

FieldValue
Enrollment Target 488 participants
Start Date 2021-10-13
Est. Completion 2023-07-27
Phase Phase 2
Massachusetts General Hospital

2,032 total trials

What the finished NCT04291508 record still lists

NCT04291508 is an interventional study that assigns participants to a tested intervention. The registered 488 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (267% higher).

The record links to 0 conditions, and to 4 interventions - of which Intravenous Acetaminophen (room temperature) is the first listed.

NCT04291508 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04291508 about?

NCT04291508 is a clinical study titled "Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery". 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.

What is the current status of trial NCT04291508?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 488 participants. The study started on 2021-10-13. Estimated completion is 2023-07-27.

What interventions are being tested in trial NCT04291508?

The interventions under investigation include: Intravenous Acetaminophen (room temperature) (DRUG), Intravenous Vitamin C (refrigerated) (DRUG), 5% Dextrose (room temperature) (DRUG), 5% Dextrose refrigerated (DRUG).

Who is sponsoring clinical trial NCT04291508?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04291508's enrollment target sits among peer trials

488 76th of 2000 higher than 1,925 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04291508, the US trial registry maintained by the National Library of Medicine. NCT04291508 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.