search
Back to results

Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach

Primary Purpose

Hypotension, Kidney Injury

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Plasmalyte 3ml/kg/hr group
Plasmalyte 6ml/kg/hr group
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring Hypotension, Kidney injury

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • between 18-89 years of age
  • undergoing pulmonary lobectomy with open or video assisted thoracotomy

Exclusion Criteria:

  • patient refusal
  • pregnancy
  • cardiac arrhythmia
  • pacemaker dependency
  • severe aortic insufficiency
  • idiopathic hypertrophic subaortic stenosis
  • prisoners
  • decisionally challenged
  • patients that refuse to receive intravenous fluid products made from human plasma (Albumin 5%)
  • patients with skin infection or breakdown on their fingers
  • severe peripheral vascular disease
  • evidence of compromised finger perfusion will be excluded

Sites / Locations

  • University of Colorado Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Plasmalyte 3ml/kg/hr group

Plasmalyte 6ml/kg/hr group

Arm Description

Outcomes

Primary Outcome Measures

Development of Renal Injury
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 indicating the most severe AKI. (1) Increase ≥ 0.3 mg per dL (26.52 μmol per L) or ≥ 1.5- to twofold from baseline. (2) Increase > two- to threefold from baseline. (3) Increase > threefold from baseline or ≥ 4.0 mg per dL (353.60 μmol per L) with an acute rise of at least 0.5 mg per dL (44.20 μmol per L).
Development of Pulmonary Edema
The number of participants diagnosed with mild to severe pulmonary edema at any time up to 72 hours after surgery is reported.

Secondary Outcome Measures

Length of Surgical Intensive Unit Stay/Hospital Stay
Length of Surgical Intensive Unit Stay/Hospital Stay
Removal of Chest Tubes
Time to removal of Chest Tubes
Development of Morbidity
Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium
Death
Death

Full Information

First Posted
May 6, 2014
Last Updated
February 24, 2020
Sponsor
University of Colorado, Denver
search

1. Study Identification

Unique Protocol Identification Number
NCT02135146
Brief Title
Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
Official Title
Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Kidney Injury
Keywords
Hypotension, Kidney injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plasmalyte 3ml/kg/hr group
Arm Type
Active Comparator
Arm Title
Plasmalyte 6ml/kg/hr group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Plasmalyte 3ml/kg/hr group
Intervention Description
This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
Intervention Type
Drug
Intervention Name(s)
Plasmalyte 6ml/kg/hr group
Intervention Description
This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
Primary Outcome Measure Information:
Title
Development of Renal Injury
Description
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 indicating the most severe AKI. (1) Increase ≥ 0.3 mg per dL (26.52 μmol per L) or ≥ 1.5- to twofold from baseline. (2) Increase > two- to threefold from baseline. (3) Increase > threefold from baseline or ≥ 4.0 mg per dL (353.60 μmol per L) with an acute rise of at least 0.5 mg per dL (44.20 μmol per L).
Time Frame
Post-op up to 72 hours
Title
Development of Pulmonary Edema
Description
The number of participants diagnosed with mild to severe pulmonary edema at any time up to 72 hours after surgery is reported.
Time Frame
Post-op up to 72 hours
Secondary Outcome Measure Information:
Title
Length of Surgical Intensive Unit Stay/Hospital Stay
Description
Length of Surgical Intensive Unit Stay/Hospital Stay
Time Frame
Up to 7 days
Title
Removal of Chest Tubes
Description
Time to removal of Chest Tubes
Time Frame
Post-op up to 48 hours
Title
Development of Morbidity
Description
Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium
Time Frame
Up to 7 days
Title
Death
Description
Death
Time Frame
Assessed up to 30 days Post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: between 18-89 years of age undergoing pulmonary lobectomy with open or video assisted thoracotomy Exclusion Criteria: patient refusal pregnancy cardiac arrhythmia pacemaker dependency severe aortic insufficiency idiopathic hypertrophic subaortic stenosis prisoners decisionally challenged patients that refuse to receive intravenous fluid products made from human plasma (Albumin 5%) patients with skin infection or breakdown on their fingers severe peripheral vascular disease evidence of compromised finger perfusion will be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamas Seres, M.D., PH.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach

We'll reach out to this number within 24 hrs