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NCT02135146 · ClinicalTrials.gov registry record · Phase 4
Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
A Phase 4 study of Hypotension and Kidney Injury, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT02135146: Completed Phase 4 study of Hypotension and Kidney Injury, sponsored by University of Colorado, Denver.
NCT02135146 is a Phase 4 study of Hypotension and Kidney Injury that has completed, run by University of Colorado, Denver. The registered enrollment target is 40 participants, below the 77-participant average among 12 other Hypotension trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02135146, a Phase 4 study of Hypotension and Kidney Injury, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to conduct a prospective, randomized, controlled trial comparing a restrictive vs. conservative fluid strategy in thoracic surgery patients. Excessive perioperative fluid has been retrospectively implicated in the development postoperative acute lung injury (PALI) and pulmonary edema following lung resection. However, fluid restriction in these patients is not without risk and may compromise end organ perfusion (i.e. acute kidney injury). The hypothesis is that a conservative fluid approach in thoracic surgery patients will result in better end organ perfusion with fewer occasions of acute kidney injury (AKI) without causing an increase in postoperative acute lung injury or pulmonary edema.
Primary Outcome
Acute renal injury as defined by the American Kidney Injury Network (AKIN) criteria in the first 72 hours postoperatively (serum creatinine levels). The AKIN scale will be used to assess the presence and severity of acute kidney injury (AKI). The AKIN is a classification/staging system of acute kidney injury developed by the Acute Kidney Injury Network which uses changes in serum creatinine (SCr) and urine output to assess AKI. Stages of acute kidney injury are defined as 1, 2, or 3, with 3 indi
Conditions Studied
Interventions
- DRUG Plasmalyte 3ml/kg/hr group
- DRUG Plasmalyte 6ml/kg/hr group
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-01 |
| Est. Completion | 2016-09 |
| Phase | Phase 4 |
What the finished NCT02135146 record still lists
NCT02135146 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 77-participant average among 12 other Hypotension trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Hypotension appearing as the primary indexed condition, and to 2 interventions - of which Plasmalyte 3ml/kg/hr group is the first listed.
NCT02135146 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT02135146 about?
NCT02135146 is a clinical study titled "Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach". The purpose of this study is to conduct a prospective, randomized, controlled trial comparing a restrictive vs. conservative fluid strategy in thoracic surgery patients. Excessive perioperative fluid has been retrospectively implicated in the development postoperative acute lung injury (PALI) and pu...
What is the current status of trial NCT02135146?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2014-01. Estimated completion is 2016-09.
What conditions does trial NCT02135146 study?
This clinical trial studies the following conditions: Hypotension, Kidney Injury.
What interventions are being tested in trial NCT02135146?
The interventions under investigation include: Plasmalyte 3ml/kg/hr group (DRUG), Plasmalyte 6ml/kg/hr group (DRUG).
Who is sponsoring clinical trial NCT02135146?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02135146 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02135146's enrollment target sits among peer trials
40 9th of 12 higher than 4 of 12 other Hypotension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypotension 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.
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