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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-09-30

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.

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Detailed Description

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Conditions

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Hypotension Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Plasmalyte 3ml/kg/hr group

Group Type ACTIVE_COMPARATOR

Plasmalyte 3ml/kg/hr group

Intervention Type DRUG

This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them

Plasmalyte 6ml/kg/hr group

Group Type ACTIVE_COMPARATOR

Plasmalyte 6ml/kg/hr group

Intervention Type DRUG

This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them

Interventions

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Plasmalyte 3ml/kg/hr group

This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them

Intervention Type DRUG

Plasmalyte 6ml/kg/hr group

This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No