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Completed

NCT Number: NCT02135146

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

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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Key information

Conditions

Hypotension Cardiovascular Diseases Kidney Injury Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Hospital

Aurora, Colorado, 80138, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasmalyte 3ml/kg/hr group

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

Drug

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

Primary outcomes

  1. Development of Renal Injury

    Time frame: Post-op up to 72 hours

    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).

  2. Development of Pulmonary Edema

    Time frame: Post-op up to 72 hours

    The number of participants diagnosed with mild to severe pulmonary edema at any time up to 72 hours after surgery is reported.

Secondary outcomes

  1. Length of Surgical Intensive Unit Stay/Hospital Stay

    Time frame: Up to 7 days

    Length of Surgical Intensive Unit Stay/Hospital Stay

  2. Removal of Chest Tubes

    Time frame: Post-op up to 48 hours

    Time to removal of Chest Tubes

  3. Development of Morbidity

    Time frame: Up to 7 days

    Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium

  4. Death

    Time frame: Assessed up to 30 days Post-op

    Death

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 9, 2014
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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