Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery

Phase 2 Completed 488 enrolled Massachusetts General Hospital

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2021-10-13
Primary completion: 2023-04-27
Completion: 2023-07-27

Publications

Ware LB, Files DC, Fowler A, Aboodi MS, Aggarwal NR, Brower RG, Chang SY, Douglas IS, Fields S, Foulkes AS, Ginde AA, Harris ES, Hendey GW, Hite RD, Huang W, Lai P, Liu KD, Thompson BT, Matthay MA; National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Clinical Trials Network. Acetaminophen for Prevention and Treatment of Organ Dysfunction in Critically Ill Patients With Sepsis: The ASTER Randomized Clinical Trial. JAMA. 2024 Aug 6;332(5):390-400. doi: 10.1001/jama.2024.8772.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	15 mg/kg	Intravenous
Comparator	Acetaminophen	Small molecule	1 g	Intravenous
Comparator	Vitamin C	Other / unclassified	50 mg/kg	Intravenous

Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery

Summary

Timeline

Publications

Drugs

Indications