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NCT01168583 Clinical Trial

Fluid Balance and Clinical Outcomes

Acute Kidney Injury Clinical Trial

Official title:
Investigation of the Effect of Post-operative Fluid Balance on Inflammatory Mediators in Patients Undergoing Cardiovascular Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01168583
Other study ID # 126-2010
Secondary ID
Status Completed
Phase N/A
First received July 22, 2010
Last updated September 19, 2011
Start date July 2010
Est. completion date June 2011

Study information
Verified date September 2011
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Shands Hospital, University of Florida Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

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