Phase 4 Completed N=40 Randomized Single-blind Treatment

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

Hypotension · Chronic Kidney Disease

Source: ClinicalTrials.gov NCT02135146 ↗

Enrolled (actual)

Serious AEs

22.5%

Results posted

Mar 2020

Primary outcomePrimary: Development of Renal Injury — 0.8; 0.74 mg/dL — p=0.31

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.