Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Growth Hormone Deficiency
• Intervention / Treatment: Procedure: 9% Sodium Chloride (NaCl) IV

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach-Tikva, Israel, 4920235
    • Schneider Children's Medical Center of Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous fluid administration; 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; 9% Sodiun Chloride (NaCl) ( 20cc/kg) adminstrated intravenously
No Intervention: Control Group; 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?

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)

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Moshe Phillip, Prof, Schneider Children's Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Growth Hormone stimulation tests
• Other Study ID Numbers: RMC068119ctil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No