Fluid Balance and Clinical Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01168583
First received: July 22, 2010
Last updated: September 19, 2011
Last verified: September 2011
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Florida

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01168583     History of Changes
Other Study ID Numbers: 126-2010
Study First Received: July 22, 2010
Last Updated: September 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014