Fluid Balance and Clinical Outcomes

NCT01168583 | Completed

• 1 other identifier: 126-2010
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fluid Balance; Input and Output; Inflammatory Mediators; Acute Kidney Injury; Mortality

Study Arms (2)

Positive Fluid Balance of 2000ml

Negative Fluid Balance of 2000ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the hospital for elective cardiothoracic surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Shands Hospital, University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (3)

• 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.

  PMID: 24002394 DERIVED

• 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.

  PMID: 22684655 DERIVED

• 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.

  PMID: 22457087 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• A Ahsan Ejaz, M.D

  University of Florida

  PRINCIPAL INVESTIGATOR

• Ganesh Kambhampati, M.D

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 23, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 21, 2011

Record last verified: 2011-09

Locations

US (1)