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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypotension, Kidney Injury

Intervention / Treatment
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* Drug: Plasmalyte 3ml/kg/hr group
* Drug: Plasmalyte 6ml/kg/hr group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plasmalyte 3ml/kg/hr group<br> | Drug: Plasmalyte 3ml/kg/hr group<br>* This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them<br>|
| Active Comparator: Plasmalyte 6ml/kg/hr group<br> | Drug: Plasmalyte 6ml/kg/hr group<br>* This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypotension, Kidney injury