Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test

NCT ID: NCT04465565

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2022-08-31

Brief 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.

Conditions

Growth Hormone Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

9% Sodium Chloride (NaCl) IV

Intervention Type: PROCEDURE

9% Sodiun Chloride (NaCl) ( 20cc/kg) adminstrated intravenously

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

9% Sodium Chloride (NaCl) IV

9% Sodiun Chloride (NaCl) ( 20cc/kg) adminstrated intravenously

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moshe Phillip, Prof

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Medical Center, Israel

Locations

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

RMC068119ctil

Identifier Type: -

Identifier Source: org_study_id