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Fluid Balance and Clinical Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168583
First Posted: July 23, 2010
Last Update Posted: September 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  Purpose
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
Fluid Balance Input and Output Inflammatory Mediators Acute Kidney Injury Mortality

Study Type: Observational
Study Design: 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

Further study details as provided by University of Florida:

Estimated Enrollment: 300
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Positive Fluid Balance of 2000ml
Negative Fluid Balance of 2000ml

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to the hospital for elective cardiothoracic surgery.
Criteria

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
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): NCT01168583


Locations
United States, Florida
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
  More Information
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