Fluid Balance and Clinical Outcomes

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

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.

Study Overview

• Status: Completed
• Conditions: Mortality; Acute Kidney Injury; Fluid Balance; Inflammatory Mediators; Input and Output

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands Hospital, University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to the hospital for elective cardiothoracic surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Positive Fluid Balance of 2000ml
Negative Fluid Balance of 2000ml

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: A Ahsan Ejaz, M.D, University of Florida; Principal Investigator: Ganesh Kambhampati, M.D, University of Florida

Publications and helpful links

General Publications

• Kambhampati G, Ejaz NI, Asmar A, Aiyer RK, Arif AA, Pourafshar N, Yalamanchili VR, Ejaz AA. Fluid balance and conventional and novel biomarkers of acute kidney injury in cardiovascular surgery. J Cardiovasc Surg (Torino). 2013 Oct;54(5):639-46. Erratum In: J Cardiovasc Surg (Torino). 2014 Feb;55(1):XII. Aiyer, R [corrected to Aiyer, R K].
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 22, 2010
• First Posted (Estimate): July 23, 2010

Study Record Updates

• Last Update Posted (Estimate): September 21, 2011
• Last Update Submitted That Met QC Criteria: September 19, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 126-2010