Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test

Study Overview
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Brief Summary
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The diagnosis of Growth Hormone deficiency in childhood requires the performance of an artificial pharmacological stimulation tests. There are number of substances that increase the secretion of growth hormone, among them Clonidine and Arginine. One of the possible side effects of both Clonidine and Arginine is a reduction in the blood pressure due to a decreased heart output and declined contraction of peripheral blood vessels. In cases where values of blood pressure at the end of the test are not recovered after two sessions of 15 minutes of physical activity, the patient is treated with I. V of 9%NORMAL SALINE (0. 20cc /Kg) administrated over 30-60 minutes. The aim of the proposed study is to test whether administration of fluids during the combined Growth Hormone stimulation test Clonidine-Arginine will help in the recovery process from the test (blood pressure > 90/50 mmHg after performing physical activity defined as 15-minutes hike in two consecutive sessions). The study design will be randomized, controlled, 2 arms study.

Official Title
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Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test- Randomized, 2 Arms, Controlled Study

Conditions
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Growth Hormone Deficiency

Intervention / Treatment
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* Procedure: 9% Sodium Chloride (NaCl) IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children referred to combined Arginine- Conidine Growth Hormone stimulation test Girls: 7-14 years old and Boys: 7-16 years old Weight>20 kg Normal thyroid function Exclusion Criteria: BMI over percentile 85 Genetic syndromes or chromosomal disorders Steroid treatment Renal failure Heart failure

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, 2 arms, controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous fluid administration<br>This arm will include 20 children who received Testoviron or Estrofem prior to the the stimulation test and 40 children who did not receive preparation prior to the stimulation test. Participants in this arm will be treated with I. V of 9%NORMAL SALINE (0. 20cc /Kg) administrated over 60 minutes. The fluids treatment will be initiated 90 minutes after the stimulation test will begin | Procedure: 9% Sodium Chloride (NaCl) IV<br>* 9% Sodiun Chloride (NaCl) ( 20cc/kg) adminstrated intravenously<br>|
| No Intervention: Control Group<br>This arm will include 20 children who received Testoviron or Estrofem prior to the the stimulation test and 40 children who did not receive preparation prior to the stimulation test. Participants in this arm will not receive fluids intravenously during the stimulation test, unless it will be required due to safety reasons | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average blood pressure | Average blood pressure ( 3 measurements in 5 minutes intervals) | Time 180 mnutes- at time of discharging the participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average blood pressure | Average blood pressure ( 3 measurements in 5 minutes intervals) | Time 0- prior to initiating the Growth Hormone test | 
| Average blood pressure | Average blood pressure ( 3 measurements in 5 minutes intervals) | Time 90 minutes after completing the Arginine adminstration | 
| Average blood pressure | Average blood pressure ( 3 measurements in 5 minutes intervals) | Time 150 minutes after completing the Arginine adminstration | 
| Time elapsed between completing the Growth Hormone test until participant is allowed to go home |  | Time 180 minutes-at time of discharging the participant (after measuring blood pressure > 50/90mm/Hg) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Growth Hormone stimulation tests