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NCT03137446 · ClinicalTrials.gov registry record · NA
Restrictive Intravenous Fluids Trial in Sepsis
A NA study, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- NA
- Development phase
- 113
- Enrollment target
NCT03137446: Completed NA study, sponsored by Rhode Island Hospital.
NCT03137446 is a NA study that has completed, run by Rhode Island Hospital. The registered enrollment target is 113 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03137446, a NA study, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 113 participants
- Enrollment target
Study Summary
IV fluid resuscitation has long been recognized to be an important treatment for patients with severe sepsis and septic shock. While under-resuscitation is known to increase morbidity and mortality, contemporary data suggests that overly aggressive fluid resuscitation may also be harmful. Currently, following an initial IVF resuscitation of 30 ml/kg, there is no standard of care and a lack of evidence to support a fluid restrictive or more liberal strategy. The investigators seek to determine if a fluid restrictive strategy reduces morbidity and mortality among patients with severe sepsis and septic shock.
Primary Outcome
Persistent Organ Dysfunction is defined as the ongoing need for vasopressor agents such as norepinephrine, epinephrine, vasopressin or dopamine for more than two hours in a given day; persistent renal failure as defined by the need for any ongoing renal replacement therapy; or persistent respiratory failure as defined by the ongoing need for mechanical ventilation at least 2 hours a day. The composite outcome will be defined as having at least one of the 4 possible composite outcomes (death, vas
Interventions
- OTHER Intravenous Fluid Cap
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2017-04-20 |
| Est. Completion | 2018-03-30 |
| Phase | NA |
What the finished NCT03137446 record still lists
NCT03137446 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Intravenous Fluid Cap is the first listed.
NCT03137446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03137446 about?
NCT03137446 is a clinical study titled "Restrictive Intravenous Fluids Trial in Sepsis". IV fluid resuscitation has long been recognized to be an important treatment for patients with severe sepsis and septic shock. While under-resuscitation is known to increase morbidity and mortality, contemporary data suggests that overly aggressive fluid resuscitation may also be harmful. Currently,...
What is the current status of trial NCT03137446?
This trial is currently completed. It is a NA study. The enrollment target is 113 participants. The study started on 2017-04-20. Estimated completion is 2018-03-30.
What interventions are being tested in trial NCT03137446?
The interventions under investigation include: Intravenous Fluid Cap (OTHER).
Who is sponsoring clinical trial NCT03137446?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03137446's enrollment target sits among peer trials
113 813th of 2000 higher than 1,188 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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