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

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ClinicalTrials.gov Identifier: NCT02135146
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hypotension Kidney Injury Drug: Plasmalyte 3ml/kg/hr group Drug: Plasmalyte 6ml/kg/hr group Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
Study Start Date : January 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Plasmalyte 3ml/kg/hr group Drug: 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
Active Comparator: Plasmalyte 6ml/kg/hr group 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135146


Locations
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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80138
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Tamas Seres, M.D., PH.D. University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02135146    
Other Study ID Numbers: 13-1900
13-1900 ( Other Identifier: COMIRB )
First Posted: May 9, 2014    Key Record Dates
Results First Posted: March 3, 2020
Last Update Posted: March 3, 2020
Last Verified: February 2020
Keywords provided by University of Colorado, Denver:
Hypotension
Kidney injury
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
 Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions