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Trial registered on ANZCTR


Registration number
ACTRN12621000857808
Ethics application status
Approved
Date submitted
14/05/2021
Date registered
2/07/2021
Date last updated
2/07/2021
Date data sharing statement initially provided
2/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validation of a Postoperative Diabetes Insipidus Prediction Tool In Patients Undergoing Skull Base Surgery
Scientific title
Validating the SALT Score for Prediction of Postoperative Diabetes Insipidus after Endoscopic Endonasal Skull Base Surgery
Secondary ID [1] 304233 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Insipidus 321935 0
Condition category
Condition code
Metabolic and Endocrine 319660 319660 0 0
Other endocrine disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will be subject to standard of care. Patients operated on for anterior skull base pathology will be scored based on imaging characteristics and intraoperative findings. The development of postoperative diabetes insipidus will be recorded in order to prospectively validate a novel predictive scoring system for the development of diabetes insipidus after endoscopic endonasal skull base surgery.

The SALT score, presented here (PMID: 34041659) is a simple scoring system based on suprasellar extension of tumour, craniopharyngioma histology, Age <50y, and intraoperative Kelly grade 3 leak.

Imaging is a preoperative volumetric gadolinium enhanced pituitary MRI and volumetric non-contrast CT brain. Both imaging modalities are performed in the week prior to surgery.
Intervention code [1] 320565 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327532 0
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.
Timepoint [1] 327532 0
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 [1] 395539 0
Requirement for supplemental antidiuretic hormone (ADH) analogue.
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.
Timepoint [1] 395539 0
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.
Secondary outcome [2] 395540 0
Discharged on Desmopressin (ddAVP) or alternative ADH analogue
This will be assessed at time of discharge by looking at the patient file and the discharge medication script
Timepoint [2] 395540 0
At time of hospital discharge from the index admission

Eligibility
Key inclusion criteria
Anterior skull base pathology designated by a multi-disciplinary team as requiring operative management via an endoscopic endonasal transsphenoidal approach
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Preoperative diabetes insipidus

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sensitivity, specificity, and receiver-operator curve for SALT Score to predict the primary outcome of the study, that is the development of postoperative DI. These calculations are all based on the primary outcome of development of postoperative DI,

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19455 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 19456 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 19457 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [4] 19458 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 34048 0
3050 - Parkville
Recruitment postcode(s) [2] 34049 0
3065 - Fitzroy
Recruitment postcode(s) [3] 34050 0
3144 - Malvern
Recruitment postcode(s) [4] 34047 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 308611 0
Self funded/Unfunded
Name [1] 308611 0
Country [1] 308611 0
Primary sponsor type
Individual
Name
Mendel Castle-Kirszbaum
Address
Department of Neurosurgery
246 Clayton Rd, Clayton 3168
Vic, Aus
Country
Australia
Secondary sponsor category [1] 309478 0
None
Name [1] 309478 0
NIl
Address [1] 309478 0
NIL
Country [1] 309478 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308543 0
Monash Health
Ethics committee address [1] 308543 0
Department of Neurosurgery
246 Clayton Rd Clayton
3168
Victoria, Australia
Ethics committee country [1] 308543 0
Australia
Date submitted for ethics approval [1] 308543 0
Approval date [1] 308543 0
01/01/2019
Ethics approval number [1] 308543 0
HREC-15386Q

Summary
Brief summary
We aim to prospectively validate a scoring system, the SALT score, in a cohort of patients with anterior skull base tumours undergoing endoscopic endonasal skull base surgery. We will assess how much patients drink and urinate in the days after surgery, as well as routine blood tests, to establish if patients develop diabetes insipidus, a condition where patients are not able to concentrate their urine. We will then assess whether the SALT score was able to predict which patients developed diabetes insipidus.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111078 0
Dr Mendel Castle-Kirszbaum
Address 111078 0
Department of Neurosurgery
Monash Health
246 Clayton Rd
Clayton 3168
Victoria, Australia
Country 111078 0
Australia
Phone 111078 0
+61395944666
Fax 111078 0
Email 111078 0
mendel.castle-kirszbaum@monashhealth.org
Contact person for public queries
Name 111079 0
Dr Mendel Castle-Kirszbaum
Address 111079 0
Department of Neurosurgery
Monash Health
246 Clayton Rd
Clayton 3168
Victoria, Australia
Country 111079 0
Australia
Phone 111079 0
+61395944666
Fax 111079 0
Email 111079 0
mendel.castle-kirszbaum@monashhealth.org
Contact person for scientific queries
Name 111080 0
Dr Mendel Castle-Kirszbaum
Address 111080 0
Department of Neurosurgery
Monash Health
246 Clayton Rd
Clayton 3168
Victoria, Australia
Country 111080 0
Australia
Phone 111080 0
+61395944666
Fax 111080 0
Email 111080 0
mendel.castle-kirszbaum@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.