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

Phase 4

Completed

• Conditions: Hypotension; Kidney Injury
• Interventions: Drug: Plasmalyte 3ml/kg/hr group; Drug: Plasmalyte 6ml/kg/hr group

• Registration Number: NCT02135146
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2020-02
• Results First Submitted: 2020-02-24
• Results First Submitted QC: 2020-02-24
• Last Update Submitted: 2020-02-24
• Results First Posted: 2020-03-03
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasmalyte 3ml/kg/hr group	Plasmalyte 3ml/kg/hr group	-
Plasmalyte 6ml/kg/hr group	Plasmalyte 6ml/kg/hr group	-

Primary Outcome Measures

Name	Time	Method
Development of Renal Injury	Post-op up to 72 hours	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	Post-op up to 72 hours	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

Name	Time	Method
Death	Assessed up to 30 days Post-op	Death
Development of Morbidity	Up to 7 days	Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium
Length of Surgical Intensive Unit Stay/Hospital Stay	Up to 7 days	Length of Surgical Intensive Unit Stay/Hospital Stay
Removal of Chest Tubes	Post-op up to 48 hours	Time to removal of Chest Tubes

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States