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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

Tracking Information
First Submitted Date  ICMJE May 6, 2014
First Posted Date  ICMJE May 9, 2014
Results First Submitted Date  ICMJE February 24, 2020
Results First Posted Date  ICMJE March 3, 2020
Last Update Posted Date March 3, 2020
Study Start Date  ICMJE January 2014
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
  • 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
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
  • Length of Surgical Intensive Unit Stay/Hospital Stay [ Time Frame: Up to 7 days ]
    Length of Surgical Intensive Unit Stay/Hospital Stay
  • Removal of Chest Tubes [ Time Frame: Post-op up to 48 hours ]
    Time to removal of Chest Tubes
  • Development of Morbidity [ Time Frame: Up to 7 days ]
    Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium
  • Death [ Time Frame: Assessed up to 30 days Post-op ]
    Death
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
  • Length of Surgical Intensive Unit Stay/Hospital Stay [ Time Frame: Within 7 days ]
    Length of Surgical Intensive Unit Stay/Hospital Stay
  • Removal of Chest Tubes [ Time Frame: within 48 hours ]
    Time to removal of Chest Tubes
  • Morbidity [ Time Frame: Within 7 days ]
    Morbidity: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium
  • Death [ Time Frame: within 30 days ]
    Death
  • Arterial Blood Gases [ Time Frame: For first 4 hours of Surgery ]
    Arterial Blood Gases
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
Official Title  ICMJE Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypotension
  • Kidney Injury
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Plasmalyte 3ml/kg/hr group
    Intervention: Drug: Plasmalyte 3ml/kg/hr group
  • Active Comparator: Plasmalyte 6ml/kg/hr group
    Intervention: Drug: Plasmalyte 6ml/kg/hr group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2016)
40
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2014)
60
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135146
Other Study ID Numbers  ICMJE 13-1900
13-1900 ( Other Identifier: COMIRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tamas Seres, M.D., PH.D. University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP