Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test

NCT04465565 | Withdrawn

• 1 other identifier: RMC068119ctil
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Growth Hormone stimulation tests

Outcome Measures

Primary Outcomes (1)

• Average blood pressure

  Average blood pressure ( 3 measurements in 5 minutes intervals)

  Time 180 mnutes- at time of discharging the participant

Secondary Outcomes (4)

• Average blood pressure

  Time 0- prior to initiating the Growth Hormone test

• Average blood pressure

  Time 90 minutes after completing the Arginine adminstration

• Average blood pressure

  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)

Study Arms (2)

Intravenous fluid administration

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

9% Sodium Chloride (NaCl) IV PROCEDURE

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

Intravenous fluid administration

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• BMI over percentile 85
• Genetic syndromes or chromosomal disorders
• Steroid treatment
• Renal failure
• Heart failure

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, 4920235, Israel

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Moshe Phillip, Prof

  Schneider Children's Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, 2 arms, controlled study

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 10, 2020
• Study Start: December 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 22, 2022

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)