Post Operative Hyponatremia in the Renal Transplant Population

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.

Study Overview

• Status: Completed
• Conditions: Hyponatremia

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 Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in 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: 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.

Description

Inclusion Criteria:

-Presenting to hospital for renal transplantation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Etiology of hyponatremia	To evaluate potential causes of post operative hyponatremia in the renal transplant population at our institution.	up to 18 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Cemal Taner, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 10, 2011
• First Submitted That Met QC Criteria: October 19, 2011
• First Posted (Estimate): October 21, 2011

Study Record Updates

• Last Update Posted (Estimate): October 26, 2011
• Last Update Submitted That Met QC Criteria: October 25, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: hyponatremia; renal transplant
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: 11-004030