Growth Hormone DeficiencyNCT04465565
Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test
A study testing 9% Sodium Chloride (NaCl) IV in people with Growth Hormone Deficiency, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- 9% Sodium Chloride (NaCl) IV
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2020to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- BMI over percentile 85
- Genetic syndromes or chromosomal disorders
- Steroid treatment
- Renal failure
- Heart failure
Trial locations and contacts
1 site in 1 country.
Israel1 site
Schneider Children's Medical Center of Israel
Petah Tikva, 4920235
About this study
Official title: 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.
- Conditions
- Growth Hormone Deficiency
- Being tested
- 9% Sodium Chloride (NaCl) IV
- Keywords
- Growth Hormone stimulation tests
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9% Sodium Chloride (NaCl) IVProcedure or surgery
9% Sodiun Chloride (NaCl) ( 20cc/kg) adminstrated intravenously
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average blood pressure
Average blood pressure ( 3 measurements in 5 minutes intervals)
Measured: Time 180 mnutes- at time of discharging the participant
Secondary outcomes (4)
Average blood pressure
Average blood pressure ( 3 measurements in 5 minutes intervals)
Measured: Time 0- prior to initiating the Growth Hormone test
Average blood pressure
Average blood pressure ( 3 measurements in 5 minutes intervals)
Measured: Time 90 minutes after completing the Arginine adminstration
Average blood pressure
Average blood pressure ( 3 measurements in 5 minutes intervals)
Measured: Time 150 minutes after completing the Arginine adminstration
Time elapsed between completing the Growth Hormone test until participant is allowed to go home
Measured: Time 180 minutes-at time of discharging the participant (after measuring blood pressure > 50/90mm/Hg)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study startDec 2020 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: PI decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, 2 arms, controlled study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof, Principal investigator, Schneider Children's Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465565
- Sponsor's protocol ID
- RMC068119ctil
- Status last verified
- Jun 2020
- First submitted
- 3 Jul 2020
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test- Randomized, 2 Arms, Controlled Study
- ClinicalTrials.gov ID
- NCT04465565
- Acronym / sponsor ID
- RMC068119ctil
- Conditions
- Growth Hormone Deficiency
- Keywords
- Growth Hormone stimulation tests
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, 2 arms, controlled study
| Arm | Type | Receives |
|---|---|---|
| Intravenous fluid administration | Experimental | Procedure: 9% Sodium Chloride (NaCl) IVThis 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 |
| 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 |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- BMI over percentile 85
- Genetic syndromes or chromosomal disorders
- Steroid treatment
- Renal failure
- Heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9% Sodium Chloride (NaCl) IV9% Sodiun Chloride (NaCl) ( 20cc/kg) adminstrated intravenously | Procedure or surgery | Intravenous fluid administration |
Primary outcome
Average blood pressure
Time frame: Time 180 mnutes- at time of discharging the participant
Average blood pressure ( 3 measurements in 5 minutes intervals)
4 secondary outcomes
Average blood pressure
Time frame: Time 0- prior to initiating the Growth Hormone test
Average blood pressure
Time frame: Time 90 minutes after completing the Arginine adminstration
Average blood pressure
Time frame: Time 150 minutes after completing the Arginine adminstration
Time elapsed between completing the Growth Hormone test until participant is allowed to go home
Time frame: Time 180 minutes-at time of discharging the participant (after measuring blood pressure > 50/90mm/Hg)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
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Enrolling by invitationObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshe Phillip, Prof principal investigator
Schneider Children's Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 9% Sodium Chloride (NaCl) IV in people with Growth Hormone Deficiency, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average blood pressure (time frame: Time 180 mnutes- at time of discharging the participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.