Phase 4
N=40
Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
Hypotension · Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT02135146 ↗Enrolled (actual)
40
Serious AEs
22.5%
Results posted
Mar 2020
Primary outcome: Primary: Development of Renal Injury — 0.8; 0.74 mg/dL — p=0.31
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Plasmalyte 3ml/kg/hr group (Drug); Plasmalyte 6ml/kg/hr group (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Development of Renal Injury |
0.8; 0.74 | 0.31 |
| PRIMARY Development of Pulmonary Edema |
4; 3 | — |
| SECONDARY Length of Surgical Intensive Unit Stay/Hospital Stay |
0.6; 0.2 | — |
| SECONDARY Removal of Chest Tubes |
3.5; 3.7 | — |
| SECONDARY Development of Morbidity |
4; 5 | — |
| SECONDARY Death |
0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02135146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.