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Clinical Trials/NCT01456832
NCT01456832CompletedNot Applicable

Post Operative Hyponatremia in the Renal Transplant Population

Mayo Clinic1 site in 1 country225 target enrollmentStarted: January 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
225
Locations
1
Primary Endpoint
Incidence of Post-operative Hyponatremia Safety Issue?: Yes Incidence of Post-op Hyponatremia

Study Overview

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.

Detailed Description

This study is designed to determine the cause of post operative hyponatremia in renal transplant patients at the Mayo Clinic of Florida. Recently, the investigators have noted a trend in post-operative hyponatremia (low serum sodium) in patients who are recipients of both living donor and cadaveric kidneys. To improve the quality of care of this patient population, the investigators propose the investigation of the sources of this decline in serum sodium levels to determine if this is preventable. The investigators propose that a potential source of post-operative hyponatremia may be related to intra-operative factors. Currently, the intravenous fluid of choice used intra-operatively is 0.45% normal saline. The investigators hypothesize that this fluid choice contributes to post-operative hyponatremia.

To further investigate this the investigators will perform a retrospective review using the renal transplant database to collect data regarding pre-operative diagnoses, co-morbidities, and method of dialysis used in the pre-transplant period. Pre-operative serum sodium level will be compared to post-operative serum sodium levels. Data including post-operative complications, need and reasons for post-operative dialysis, and hospital course will also be collected. Once the data are analyzed and a primary source or sources are identified as causative agents for post-operative hyponatremia, an intervention to prevent a decline in serum sodium post-operatively will be planned for future study.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Presenting to hospital for renal transplantation

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: up to 18 months

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

Secondary Outcomes

  • Etiology of hyponatremia(up to 18 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

C. Burcin Taner

MD, Assistant Professor of Surgery, College of Medicine

Mayo Clinic

Study Sites (1)

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