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NCT02159079 · ClinicalTrials.gov registry record · NA
A Randomized Controlled Trial of a Conservative Fluid Balance Strategy for Patients With Sepsis and Cardiopulmonary Dysfunction (BALANCE Study)
A NA study, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT02159079 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 30 participants.
The verdict
NCT02159079, a NA study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Sepsis is a common inflammatory response to infection characterized by hypovolemia and vasodilation for which early administration of intravenous fluids has been suggested to improve outcomes. The ideal fluid balance following initial resuscitation is unclear. Septic patients treated in the intensive care unit commonly receive significant volumes of intravenous fluids with resultant positive fluid balance for up to a week after their initial resuscitation. Observational studies have associated fluid receipt and positive fluid balance in patients with severe sepsis and septic shock with increased mortality but are inherently limited by indication bias. In order to determine the optimal approach to fluid management following resuscitation in patients with severe sepsis and septic shock, a randomized controlled trial is needed. The primary hypothesis of this study is that, compared to usual care, a conservative approach to fluid management after resuscitation in patients with sepsis and cardiopulmonary dysfunction will increase intensive care unit free days.
Interventions
- OTHER Conservative Fluid Management Strategy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02159079
The ClinicalTrials.gov registry entry for NCT02159079 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Conservative Fluid Management Strategy is the first listed.
NCT02159079 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02159079 about?
NCT02159079 is a clinical study titled "A Randomized Controlled Trial of a Conservative Fluid Balance Strategy for Patients With Sepsis and Cardiopulmonary Dysfunction (BALANCE Study)". Sepsis is a common inflammatory response to infection characterized by hypovolemia and vasodilation for which early administration of intravenous fluids has been suggested to improve outcomes. The ideal fluid balance following initial resuscitation is unclear. Septic patients treated in the intensiv...
What is the current status of trial NCT02159079?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2014-07. Estimated completion is 2016-04.
What interventions are being tested in trial NCT02159079?
The interventions under investigation include: Conservative Fluid Management Strategy (OTHER).
Who is sponsoring clinical trial NCT02159079?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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