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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
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Development of Renal injury [ Time Frame: within 72 hours ]
    Acute renal injury as defined by the American Kidney Injury Network (AKIN) criteria in the first 72 hours postoperatively

  2. Development of Pulmonary Edema [ Time Frame: Within 72 hours ]
    Pulmonary Edema-as diagnosed independently by two, blinded radiologists using chest x-ray on postoperative day 0,1, and 2. Pulmonary edema will be classified as none, mild, moderate or severe.


Secondary Outcome Measures :
  1. Length of Surgical Intensive Unit stay/hospital Stay [ Time Frame: Within 7 days ]
    Length of Surgical Intensive Unit stay/hospital Stay

  2. Removal of Chest Tubes [ Time Frame: within 48 hours ]
    Time to removal of Chest Tubes

  3. Development of Morbidity [ Time Frame: Within 7 days ]
    Morbidity: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium

  4. Death [ Time Frame: within 30 days ]
    Death

  5. Change in Arterial Blood Gases [ Time Frame: For first 4 hours of Surgery ]
    Arterial Blood Gases



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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

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

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02135146     History of Changes
Other Study ID Numbers: 13-1900
13-1900 ( Other Identifier: COMIRB )
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
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