Use of Copeptin Measurement After Arginine Infusion for the Differential Diagnosis of Diabetes Insipidus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2022-12-31

Brief Summary

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The differential diagnosis of central diabetes insipidus (cDI) is difficult and the current test with the highest diagnostic accuracy is copeptin measurement after hypertonic saline infusion (HIS). Although the HIS improved diagnostic accuracy compared to the standard water deprivation test used for decades before, it still comprises great discomfort for patients due to the rise in serum sodium levels above 149mmol/l and requires the presence of medical staff at all times to guarantee safety of the test.

The arginine stimulation test is routinely used to stimulate growth hormone. Own data in 52 patients with polyuria / polydipsia syndrome showed that arginine infusion is a potent stimulator of the neurohypophysis and provides a new diagnostic tool in the differential diagnosis of cDI. Copeptin measurements upon arginine stimulation (CAS) discriminated patients with diabetes insipidus vs. patients with primary polydipsia with a high diagnostic accuracy of 94%.

To validate these results and to compare them against the HIS a large multicenter trial is needed, where the diagnostic accuracy of the CAS is compared to the HIS.

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Detailed Description

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Conditions

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Diabetes Insipidus Polydipsia, Primary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Observational randomized cross-over diagnostic international multicenter study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arginine Infusion

Arginine Stimulation Test

Group Type EXPERIMENTAL

Arginine infusion

Intervention Type DIAGNOSTIC_TEST

Intravenous Infusion of Arginine is given, copeptin measurement will be collected before and 60minutes after start of infusion

Hypertonic saline infusion

Hypertonic Saline Infusion Test

Group Type ACTIVE_COMPARATOR

Hypertonic saline infusion

Intervention Type DIAGNOSTIC_TEST

Intravenous Infusion of hypertonic Saline is given, copeptin measurement will be collected before and once Plasma sodium rises above 149mmol/l

Interventions

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Arginine infusion

Intravenous Infusion of Arginine is given, copeptin measurement will be collected before and 60minutes after start of infusion

Intervention Type DIAGNOSTIC_TEST

Hypertonic saline infusion

Intravenous Infusion of hypertonic Saline is given, copeptin measurement will be collected before and once Plasma sodium rises above 149mmol/l

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Hypotonic polyuria / polydipsia syndrome defined as: polyuria \>50ml/kg body weight/24h and polydipsia \>3l /24h or known diabetes insipidus under treatment with DDAVP
* Urine-Osmolality \<800mOsm/L

Exclusion Criteria

* Polyuria / polydipsia secondary to diabetes mellitus, hypercalcemia or hypokalemia
* Nephrogenic diabetes insipidus (defined as baseline copeptin level \>21.4pmol/L)
* Evidence of any acute illness
* Epilepsy requiring treatment
* Uncontrolled arterial hypertension (blood pressure \>160/100mmHg at baseline)
* Cardiac failure (NYHA III-IV)
* Liver cirrhosis (Child B-C)
* Uncorrected adrenal or thyroidal deficiency
* Patients refusing or unable to give written informed consent
* Pregnancy or breast feeding
* End of life care

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No