Pulmonary Hypertensive CrisisPhase 2NCT01668277
Effects of Saline on Circulation in Children
A Phase 2 study testing 7.2% NaCl and 0.9% NaCl in people with Pulmonary Hypertensive Crisis, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
Pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure in the pulmonary artery, vein, and capillaries. Infusion of hypertonic saline solutions expand the circulating volume, thus allowing more blood to flow and reducing pressure in the artery, vein, and capillaries. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pulmonary Hypertensive Crisis
- What is being tested?
- 7.2% NaCl and 0.9% NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2012to Dec 2014
- Phase
- Phase 2
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children who have had a heart transplant and are scheduled for elective endomyocardial biopsies during general anaesthesia
- Age > 2 years
Who cannot join
- Plasma Na < 130 mmol/l or >150 mmol/l
- Refusal of consent
- An estimated pulmonary arterial pressure which is greater than or equal to 66% of systemic blood pressure
- Children with heart failure (right and/or left), i.e clinical suspicion by either a cardiologist or an anesthesiologist of inability to tolerate a fluid bolus of 3 ml/kg 7.2% NaCl corresponding to an expansion of the circulatory volume by approximately 9% (see the section on safety), which is the equivalent of infusion approximately 20 ml/kg 0.9% NaCl over 10 minutes.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hospital For Sick Children
Toronto, Ontario, M5G 1X8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: Effects of Hypertonic Saline on the Pulmonary Circulation in Children
Pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure in the pulmonary artery, vein, and capillaries. Infusion of hypertonic saline solutions expand the circulating volume, thus allowing more blood to flow and reducing pressure in the artery, vein, and capillaries. Furthermore, infusion of hypertonic saline has been shown to reduce both systemic and pulmonary vascular resistances in adults. If the pulmonary vascular resistance decreases more or to the same degree as the systemic resistance, infusion of hypertonic saline may prove beneficial in the treatment of pulmonary hypertensive crisis. The primary objective of this study is to investigate how a clinically relevant dose of hypertonic saline affects the systemic and pulmonary circulations in children undergoing cardiac catheterization during general anesthesia. This study hypothesizes that an infusion of hypertonic saline over 10 minutes will reduce the pulmonary vascular resistance more than the systemic vascular resistance.
- Conditions
- Pulmonary Hypertensive Crisis
- Being tested
- 7.2% NaCl, 0.9% NaCl
- Keywords
- Pulmonary Hypertensive Crisis, Pediatrics, Hypertonic Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7.2% NaClDrug
0.9% NaClDrug
| Study group | Role | What they receive |
|---|---|---|
| 3 ml/kg 7.2% NaCl | Experimental | The test fluids 7.2% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion. Receives: Drug: 7.2% NaCl |
| 3 ml/kg 0.9% NaCl | Active comparator | The test fluids 0.9% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion. Receives: Drug: 0.9% NaCl |
| 20 ml/kg 0.9% NaCl | Active comparator | The test fluids 0.9% NaCl 20 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion. Receives: Drug: 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Vascular Resistance Index
Pulmonary vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.
Measured: Change from Baseline in Pulmonary Vascular Resistance Index after 1 hour
Systemic Vascular Resistance Index
Systemic vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.
Measured: Change from Baseline in Systemic Vascular Resistance Index after 1 hour
Cardiac Index
Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization.
Measured: Change from Baseline in Cardiac Index after 1 hour
Secondary outcomes (3)
Blood Gas
Effect on blood hemoglobin, plasma potassium and sodium, measured on a blood gas analyzer
Measured: Average over 1 hour
Plasma Volume
Effect on plasma volume calculated from the change in blood hemoglobin
Measured: Average over 1 hour
Atrial Natriuretic Peptide
Effect on atrial natriuretic peptide
Measured: Average over 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertensive CrisisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Taylor, The Hospital for Sick Children
- Investigators
- Katherine Taylor, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668277
- Sponsor's protocol ID
- 1000026525
- Status last verified
- Oct 2020
- First submitted
- 8 Aug 2012
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypertonic Saline on the Pulmonary Circulation in Children
- ClinicalTrials.gov ID
- NCT01668277
- Acronym / sponsor ID
- 1000026525
- Conditions
- Pulmonary Hypertensive Crisis
- Keywords
- Pulmonary Hypertensive Crisis, Pediatrics, Hypertonic Saline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Aug 2012 (estimated)
- 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.
Pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure in the pulmonary artery, vein, and capillaries. Infusion of hypertonic saline solutions expand the circulating volume, thus allowing more blood to flow and reducing pressure in the artery, vein, and capillaries. Furthermore, infusion of hypertonic saline has been shown to reduce both systemic and pulmonary vascular resistances in adults. If the pulmonary vascular resistance decreases more or to the same degree as the systemic resistance, infusion of hypertonic saline may prove beneficial in the treatment of pulmonary hypertensive crisis. The primary objective of this study is to investigate how a clinically relevant dose of hypertonic saline affects the systemic and pulmonary circulations in children undergoing cardiac catheterization during general anesthesia. This study hypothesizes that an infusion of hypertonic saline over 10 minutes will reduce the pulmonary vascular resistance more than the systemic vascular resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 ml/kg 7.2% NaCl | Experimental | Drug: 7.2% NaClThe test fluids 7.2% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion. |
| 3 ml/kg 0.9% NaCl | Active comparator | Drug: 0.9% NaClThe test fluids 0.9% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion. |
| 20 ml/kg 0.9% NaCl | Active comparator | Drug: 0.9% NaClThe test fluids 0.9% NaCl 20 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children who have had a heart transplant and are scheduled for elective endomyocardial biopsies during general anaesthesia
- Age > 2 years
Key exclusion criteria (4 listed)
- Plasma Na < 130 mmol/l or >150 mmol/l
- Refusal of consent
- An estimated pulmonary arterial pressure which is greater than or equal to 66% of systemic blood pressure
- Children with heart failure (right and/or left), i.e clinical suspicion by either a cardiologist or an anesthesiologist of inability to tolerate a fluid bolus of 3 ml/kg 7.2% NaCl corresponding to an expansion of the circulatory volume by approximately 9% (see the section on safety), which is the equivalent of infusion approximately 20 ml/kg 0.9% NaCl over 10 minutes.
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 |
|---|---|---|
| 7.2% NaCl | Drug | 3 ml/kg 7.2% NaCl |
| 0.9% NaCl | Drug | 20 ml/kg 0.9% NaCl, 3 ml/kg 0.9% NaCl |
Primary outcome
Pulmonary Vascular Resistance Index
Time frame: Change from Baseline in Pulmonary Vascular Resistance Index after 1 hour
Pulmonary vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.
Systemic Vascular Resistance Index
Time frame: Change from Baseline in Systemic Vascular Resistance Index after 1 hour
Systemic vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.
Cardiac Index
Time frame: Change from Baseline in Cardiac Index after 1 hour
Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization.
3 secondary outcomes
Blood Gas
Time frame: Average over 1 hour
Plasma Volume
Time frame: Average over 1 hour
Atrial Natriuretic Peptide
Time frame: Average over 1 hour
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
Related trials for Pulmonary Hypertensive Crisis
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Recruiting
Home Hospital for Suddenly Ill Adults
Infection, Heart Failure
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.
Katherine Taylor, MD principal investigator
The Hospital for Sick Children
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 7.2% NaCl and 0.9% NaCl in people with Pulmonary Hypertensive Crisis, run by The Hospital for Sick Children at 2 sites in Canada.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Pulmonary Vascular Resistance Index (time frame: Change from Baseline in Pulmonary Vascular Resistance Index after 1 hour). The study lists 3 primary outcomes in all. 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 2 Nov 2020.