Post Operative Hyponatremia in the Renal Transplant Population

NCT01456832 | Completed

• 1 other identifier: 11-004030
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine the causes of low sodium (salt) in the body fluids outside the cells for patients who have received a kidney transplant at the Mayo Clinic of Florida. The investigators will look at data collected on previous transplant patients at the Mayo Clinic to determine if the low sodium levels could be related to factors occurring in the course of surgery. The investigators hypothesize that the intravenous fluid used in the surgery, which is about half the concentration of normal saline, could contribute to the low sodium levels.

Conditions

Hyponatremia

Keywords

hyponatremia; renal transplant

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-operative Hyponatremia Safety Issue?: Yes Incidence of Post-op Hyponatremia

  To study the incidence of post operative hyponatremia in patients undergoing renal transplant at our institution.

  up to 18 months

Secondary Outcomes (1)

• Etiology of hyponatremia

  up to 18 months

Study Arms (1)

Renal Transplant Patients with Post-operative Hypoatremia

All renal transplant recipients at the Mayo Clinic of Florida from 1/1/2010 through 8/19/2011 who received a kidney from either a living or cadaveric donor.

Eligibility Criteria

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

Study Population

All renal transplant recipients who received a kidney transplant from either a living or cadaveric donor from 1/1/2010 through 8/19/2011 and subsequently developed post-operative hyponatremia.

You may qualify if:

• Presenting to hospital for renal transplantation

You may not qualify if:

• Renal transplant recipients who received simultaneous transplantation of a liver, heart, or lung

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Cemal Taner, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor of Surgery, College of Medicine

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 21, 2011
• Study Start: January 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 26, 2011

Record last verified: 2011-10

Locations

US (1)