Post Operative Hyponatremia in the Renal Transplant Population

Hyponatremia Clinical Trial

Official title:

Post Operative Hyponatremia in the Renal Transplant Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456832
• Other study ID #: 11-004030
• Status: Completed
• Phase: N/A
• First received: October 10, 2011
• Last updated: October 25, 2011
• Start date: January 2010
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Presenting to hospital for renal transplantation

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hyponatremia

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Etiology of hyponatremia	To evaluate potential causes of post operative hyponatremia in the renal transplant population at our institution.	up to 18 months	Yes