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

• 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: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Tracking Information

• First Submitted Date: May 6, 2014
• First Posted Date: May 9, 2014
• Results First Submitted Date: February 24, 2020
• Results First Posted Date: March 3, 2020
• Last Update Posted Date: March 3, 2020
• Study Start Date: January 2014
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Hypotension
• Kidney Injury

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 1, 2016): 40
• Original Estimated Enrollment (submitted: May 7, 2014): 60
• Actual Study Completion Date: September 2016
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 89 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02135146
• Other Study ID Numbers: 13-1900; 13-1900 ( Other Identifier: COMIRB )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Colorado, Denver
• Study Sponsor: University of Colorado, Denver
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tamas Seres, M.D., PH.D.; University of Colorado, Denver

• PRS Account: University of Colorado, Denver
• Verification Date: February 2020