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Fluid Balance and Clinical Outcomes

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT01168583
Collaborator
(none)
300
Enrollment
1
Location
11
Duration (Months)
27.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is about investigating the relationship of postoperative fluid balance, inflammation and acute kidney injury. This is a non-interventional study (no drug administration). The investigators will collect baseline demographic data, postoperative fluid balance status by Intake-output data, follow routine labs and collect 1 blood sample (0.5ml) with morning lab draws on day 1 and 5ml urine samples on day 1 and 2.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Investigation of the Effect of Post-operative Fluid Balance on Inflammatory Mediators in Patients Undergoing Cardiovascular Surgery
    Study Start Date :
    Jul 1, 2010
    Actual Primary Completion Date :
    Jun 1, 2011
    Actual Study Completion Date :
    Jun 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Positive Fluid Balance of 2000ml
    Negative Fluid Balance of 2000ml

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Age 18 years or older, and

      • Undergoing elective cardiothoracic surgery(s), alone or in combination with other procedures/surgery(s): thoracic aortic aneurysm, cardiac valves, coronary artery bypass grafting, abdominal thoracic aneurysm, and other cardiovascular surgery.

      Exclusion Criteria:

      • Pregnancy

      • History of any organ transplant

      • Preoperative intra-aortic balloon pump (IABP)

      • Current use of natriuretic peptides

      • ESRD patients on dialysis

      • Estimated GFR < 30ml/min using MDRD equation.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Shands Hospital, University of Florida Gainesville Florida United States 32610

      Sponsors and Collaborators

      • University of Florida

      Investigators

      • Principal Investigator: A Ahsan Ejaz, M.D, University of Florida
      • Principal Investigator: Ganesh Kambhampati, M.D, University of Florida

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University of Florida
      ClinicalTrials.gov Identifier:
      NCT01168583
      Other Study ID Numbers:
      • 126-2010
      First Posted:
      Jul 23, 2010
      Last Update Posted:
      Sep 21, 2011
      Last Verified:
      Sep 1, 2011
      Additional relevant MeSH terms:
      Acute Kidney Injury

      Study Results

      No Results Posted as of Sep 21, 2011