Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test

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Brief Title

Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

Average blood pressure

Secondary Outcome

 Average blood pressure

Condition

Growth Hormone Deficiency

Intervention

9% Sodium Chloride (NaCl) IV

Study Arms / Comparison Groups

 Intravenous fluid administration
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

0

Start Date

December 2020

Completion Date

August 2022

Primary Completion Date

August 2022

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
      

Gender

All

Ages

7 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

Moshe Phillip, Prof, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT04465565

Organization ID

RMC068119ctil


Responsible Party

Sponsor

Study Sponsor

Rabin Medical Center


Study Sponsor

Moshe Phillip, Prof, Principal Investigator, Schneider Children's Medical Center, Israel


Verification Date

June 2020