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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 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.

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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.

Interventions

  • DRUG Plasmalyte 3ml/kg/hr group
  • DRUG Plasmalyte 6ml/kg/hr group

Study Locations (1)

Colorado

  • University of Colorado Hospital - Aurora

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2014-01
Est. Completion 2016-09
Phase Phase 4

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT02135146

The ClinicalTrials.gov registry entry for NCT02135146 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 77-participant average among 12 other Hypotension trials with a reported enrollment target (48% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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