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NCT03434028 · ClinicalTrials.gov registry record · Phase 3
Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,563
- Enrollment target
NCT03434028: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT03434028 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 1,563 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03434028, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,563 participants
- Enrollment target
Study Summary
Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension.
Primary Outcome
The primary outcome was death from any cause before discharge home by day 90. Point estimates were from Kaplan-Meier curves. There were 109 deaths and 5 patients with censored data the restrictive fluid group and 116 deaths and 4 patients with censored data in the liberal group. We defined home as the same setting or a setting similar to the one where the patient resided before becoming ill. Thus, if a patient originated from a private residence and was discharged from the hospital to a rehabili
Interventions
- DRUG Early Vasopressors
- OTHER Early Fluids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,563 participants |
| Start Date | 2018-03-07 |
| Est. Completion | 2022-08-24 |
| Phase | Phase 3 |
What the finished NCT03434028 record still lists
NCT03434028 is an interventional study that assigns participants to a tested intervention. Its 1,563 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (102% higher).
The record links to 0 conditions, and to 2 interventions - of which Early Vasopressors is the first listed.
NCT03434028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03434028 about?
NCT03434028 is a clinical study titled "Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis". Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue flui...
What is the current status of trial NCT03434028?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,563 participants. The study started on 2018-03-07. Estimated completion is 2022-08-24.
What interventions are being tested in trial NCT03434028?
The interventions under investigation include: Early Vasopressors (DRUG), Early Fluids (OTHER).
Who is sponsoring clinical trial NCT03434028?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03434028's enrollment target sits among peer trials
1,563 150th of 2000 higher than 1,851 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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