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

History of Changes

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):

Ejaz AA, Kambhampati G, Ejaz NI, Dass B, Lapsia V, Arif AA, Asmar A, Shimada M, Alsabbagh MM, Aiyer R, Johnson RJ. Post-operative serum uric acid and acute kidney injury. J Nephrol. 2012 Jul-Aug;25(4):497-505. doi: 10.5301/jn.5000173.

Kambhampati G, Ross EA, Alsabbagh MM, Asmar A, Pakkivenkata U, Ejaz NI, Arif AA, Ejaz AA. Perioperative fluid balance and acute kidney injury. Clin Exp Nephrol. 2012 Oct;16(5):730-8. doi: 10.1007/s10157-012-0623-5. Epub 2012 Mar 29.

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
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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