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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014