Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test

Growth Hormone Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04465565
• Other study ID #: RMC068119ctil
• Status: Withdrawn
• Phase: N/A
• Start date: December 2020
• Est. completion date: August 2022

Study information

• Verified date: June 2020
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Growth Hormone Deficiency

Intervention

Procedure:
• 9% Sodium Chloride (NaCl) IV
9% Sodiun Chloride (NaCl) ( 20cc/kg) adminstrated intravenously

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average blood pressure	Average blood pressure ( 3 measurements in 5 minutes intervals)	Time 180 mnutes- at time of discharging the participant
Secondary	Average blood pressure	Average blood pressure ( 3 measurements in 5 minutes intervals)	Time 0- prior to initiating the Growth Hormone test
Secondary	Average blood pressure	Average blood pressure ( 3 measurements in 5 minutes intervals)	Time 90 minutes after completing the Arginine adminstration
Secondary	Average blood pressure	Average blood pressure ( 3 measurements in 5 minutes intervals)	Time 150 minutes after completing the Arginine adminstration
Secondary	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)