Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Development of Renal Injury
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Plasmalyte 3ml/kg/hr group
Intervention: Plasmalyte 3ml/kg/hr group (Drug)
Plasmalyte 6ml/kg/hr group
Intervention: Plasmalyte 6ml/kg/hr group (Drug)
Outcomes
Primary Outcomes
Development of Renal Injury
Time Frame: 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
Time Frame: 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 Outcomes
- Death(Assessed up to 30 days Post-op)
- Development of Morbidity(Up to 7 days)
- Length of Surgical Intensive Unit Stay/Hospital Stay(Up to 7 days)
- Removal of Chest Tubes(Post-op up to 48 hours)