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

University of Colorado, Denver40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hypotension Kidney Injury

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: Post-op up to 72 hours

Secondary Outcomes

Length of Surgical Intensive Unit Stay/Hospital Stay

Time frame: Up to 7 days

Removal of Chest Tubes

Time to removal of Chest Tubes

Time frame: Post-op up to 48 hours

Development of Morbidity

Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium