Validation of a Postoperative Diabetes Insipidus Prediction Tool In Patients Undergoing Skull Base Surgery

Not Applicable

Recruiting

• Conditions: Diabetes Insipidus; Metabolic and Endocrine - Other endocrine disorders

• Registration Number: ACTRN12621000857808
• Lead Sponsor: Mendel Castle-Kirszbaum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-02
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Anterior skull base pathology designated by a multi-disciplinary team as requiring operative management via an endoscopic endonasal transsphenoidal approach

Exclusion Criteria

Preoperative diabetes insipidus

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of postoperative diabetes insipidus. DI is defined as a polyuria polydipsia syndrome of hypotonic urine. Urine hypotonicity is defined by either sodium potassium sum (e.g. UNa+UK less than 40mmol/L) or urine osmolarity. Polyuria is defined as urine output of greater than 250ml/h for 2 or more consecutive hours. A diagnosis of DI is then confirmed by the endocrinology treating team. Data is collected from the patient notes.[Urine output is checked hourly for the first 3 postoperative days, and urine samples are taken twice daily. Our primary endpoint is development of DI during the index hospital admission, which is typically 4-5 days.]

Secondary Outcome Measures

Name	Time	Method
Requirement for supplemental antidiuretic hormone (ADH) analogue. <br>After a diagnosis of DI, if the patient is unable to maintain water balance through the thirst response they are administered an antidiuretic hormone analogue, after discussion with the endocrinology team. This is assessed by analysis of the patient file.[Our secondary endpoint is requirement for suppplemental ADH analogue during the index hospital admission, which is typically 4-5 days. This is assessed once the patient is discharged. A single dose, or ongoing dosing is considered as meeting this endpoint.];Discharged on Desmopressin (ddAVP) or alternative ADH analogue<br>This will be assessed at time of discharge by looking at the patient file and the discharge medication script[At time of hospital discharge from the index admission]