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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135146
• Other study ID #: 13-1900
• Secondary ID: 13-1900
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: September 2016

Study information

• Verified date: February 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Kidney Injury

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

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