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Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)

NCT03636568 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-07-23

No results posted yet for this study

Summary

Hyponatremia is defined as sodium below the normal range of 135-145. Symptomatically, it can cause patients to experience a wide range of symptoms including lethargy, headache, nausea, vomiting and in severe cases coma and even death. The goal of this study is to prospectively compare two approaches to the postoperative fluid management of patients undergoing transsphenoidal resection of a pituitary tumor or cyst to decrease the occurrence of postoperative delayed hyponatremia. One group will be placed on moderate fluid restriction and the other group will be placed on ad lib fluid intake.

Conditions

  • Hyponatremia
  • Hyponatremic
  • Pituitary Tumor
  • Pituitary
  • Surgery

Interventions

OTHER

Fluid Restricted Group

Patients will be started on a weight-based intravenous fluid replacement with D5 ½ NS on POD 0 (75 cc/hr for patients \< 70kg, 100 cc/hr for patients 70-100kg, and 125 cc/hr for patients \>100kg). Patients will be allowed to drink water freely after surgery on POD #0. Fluids will be stopped at 8am on POD 1 and patients will be started on a moderate fluid restriction on POD #3 based on their weight (1000 cc/24 hours for patients who weigh \<=100 kg and 1200 cc/24 hours for patients who weigh \> 100kg). Prior to initiation of a fluid restriction all of the following criteria have to be met: 1. Serum Na level must be \< 145 mEq/l 2. Patient should be taking fluids by mouth 3. Patient should not have evidence of DI (as determined by endocrine team following patient) If a patient in Fluid Restricted group develops DI, the fluid restriction will be stopped/not initiated.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Julie Silverstein, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-02
Primary Completion
2024-07-22
Completion
2024-07-22

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03636568 on ClinicalTrials.gov