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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status and phase

Completed
Phase 4

Conditions

Hypotension
Kidney Injury

Treatments

Drug: Plasmalyte 6ml/kg/hr group
Drug: Plasmalyte 3ml/kg/hr group

Study type

Interventional

Funder types

Other

Identifiers

NCT02135146
13-1900 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Plasmalyte 3ml/kg/hr group
Active Comparator group
Treatment:
Drug: Plasmalyte 3ml/kg/hr group
Plasmalyte 6ml/kg/hr group
Active Comparator group
Treatment:
Drug: Plasmalyte 6ml/kg/hr group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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