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IV Acetaminophen-Active for Sepsis (ASTER Trial)

Phase 2
Waitlist Available
Led By Boyd Taylor Thompson, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 90
Awards & highlights

ASTER Trial Summary

This trial is studying two different drugs to treat sepsis-induced hypotension or respiratory failure.

Eligible Conditions
  • Sepsis
  • Critical Illness
  • Acute Respiratory Distress Syndrome
  • Respiratory Failure

ASTER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Days alive and free of organ support to day 28
Secondary outcome measures
28-day hospital mortality
90-day all-cause mortality
90-day hospital mortality
+14 more

ASTER Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: IV Acetaminophen-ActiveActive Control1 Intervention
Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses).
Group II: IV Vitamin C-ActiveActive Control1 Intervention
Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed.
Group III: Acetaminophen-PlaceboPlacebo Group1 Intervention
Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses).
Group IV: Vitamin C-PlaceboPlacebo Group1 Intervention
Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). Note: This arm is now closed.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,929 Previous Clinical Trials
13,197,817 Total Patients Enrolled
7 Trials studying Sepsis
5,318 Patients Enrolled for Sepsis
Boyd Taylor Thompson, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
1,837 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical problems can be addressed through the use of IV Vitamin C-Active?

"Intravenous Vitamin C-Active is the go-to treatment for cases of diarrhoea. This medication has also proven effective at alleviating conditions such as rhinorrhoea, catarrh, and vitamin deficiency."

Answered by AI

Is there a precedent for employing IV Vitamin C-Active in clinical studies?

"In 2007, the first study on IV Vitamin C-Active was conducted at Centennial Medical Center. Since then, 862 clinical trials have been concluded and currently 149 experiments are underway - with many of these sites located in Murray, Utah."

Answered by AI

Is there still capacity to include more participants in this research endeavor?

"The clinical trial hosted on the website clinicaltrials.gov is actively seeking participants, having been posted to the site on October 13th 2021 and most recently updated September 9th 2022."

Answered by AI

What is the approximate census of participants in this experiment?

"Affirmative. Per the information from clinicaltrials.gov, this research project is still in its recruitment phase. The trial was first advertised on October 13th 2021 and it has most recently been updated on September 9th 2022; 900 participants are needed to be enrolled at 48 distinct sites."

Answered by AI

Is there any risk associated with intravenous Vitamin C-Active consumption?

"Considering the Phase 2 status of IV Vitamin C-Active, our team at Power has assigned it a safety rating of 2 due to a lack of efficacy data alongside existing evidence supporting its security."

Answered by AI

In how many distinct locations is the trial being conducted?

"This clinical trial has presence in 48 locations, including Intermountain Medical Center located in Murray, Massachusetts General Hospital based in Boston and Sentara/EVMS situatedin Norfolk."

Answered by AI
~139 spots leftby Apr 2025