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 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.

Study Overview

• Status: Completed
• Conditions: Hypotension; Kidney Injury
• Intervention / Treatment: Drug: Plasmalyte 3ml/kg/hr group; Drug: Plasmalyte 6ml/kg/hr group

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80138
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plasmalyte 3ml/kg/hr group	Drug: Plasmalyte 3ml/kg/hr group; This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
Active Comparator: Plasmalyte 6ml/kg/hr group	Drug: Plasmalyte 6ml/kg/hr group; This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Post-op up to 72 hours
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.	Post-op up to 72 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Tamas Seres, M.D., PH.D., University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 7, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Hypotension; Kidney injury
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: 13-1900 (Other Identifier: COMIRB)