Congenital Heart Disease (CHD)NCT02806245
Biventricular Pacing in Children After Surgery for Congenital Heart Disease
A study testing Biventricular pacing in people with Congenital Heart Disease (CHD), run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased and emphasis has shifted to post-operative morbidity and recovery. Read more about this study
- Who is it for?
- Ages 1 day to 4 months
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- Biventricular pacing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2007to Dec 2013
- 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 1 day to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- < 4 months of age at time of surgery
- Surgery for congenital heart disease requiring cardiopulmonary bypass
- Reparative surgery to achieve biventricular cardiac physiology.
- Sinus rhythm.
Who cannot join
- Isolated atrial septal defect repair.
- Surgery without cardiopulmonary bypass.
- Palliative surgery.
- Single ventricle physiology.
- Age > 4 months at time of surgery
- Clinical indication for pacing (e.g. iatrogenic heart block)
Show all 10Show fewer
- Arrhythmia
- Second or third degree heart block.
- Patient with known bleeding disorder
- Patient requires ECMO in operating room (eg. unable to wean from cardio-pulmonary bypass or hemodynamic/ respiratory instability that requires ECMO in OR). These patients return from the OR to the ICU on ECMO.
Trial locations and contacts
1 site in 1 country.
About this study
Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased and emphasis has shifted to post-operative morbidity and recovery. Children with CHD undergoing surgery with CPB can experience well-characterized post-operative cardiac dysfunction. When severe, patients can develop clinically important low cardiac output syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise is primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine, which affect the strength of the heart's muscular contractions. These are used to maintain adequate blood pressure (BP) and CI. However, inotropic agents are potentially detrimental to myocardial function and may increase risk for post-operative arrhythmia and impair post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2). In combination with the increased VO2 associated with CPB-induced systemic inflammatory response patients can develop a critical mismatch between oxygen supply and demand, essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic stability without increased VO2 are beneficial. This study will test whether BiVp, a specialized yet simple pacing technique, can improve post-operative CI and recovery in infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study hypothesizes that Continuous BiVp increases the mean change in CI from baseline to 72 hours in infants with EMD following CHD surgery compared to standard care alone.
Read the detailed description
In adults with heart failure with intrinsic or iatrogenic left bundle branch block (eg, RV pacing), and more recently in those with narrow QRS complex, pacing the heart with advanced pacing techniques from both the left and right ventricle (LV, RV) termed cardiac resynchronization therapy (CRT) improves resting systolic heart function and mechanoenergetics.1 In these patients, CRT has been shown to increase LV stroke volume, ejection fraction, and stroke work, resulting in an enhancement of LV myocardial efficiency, without an increase in oxidative metabolism and even a decrease in energy utilization.2-4 Furthermore, oxygen consumption seems to be distributed more homogeneously during CRT.2 Beyond increasing resting myocardial efficiency, CRT may increase metabolic reserve as judged by the increase in cardiac work in response to dobutamine.5 CRT has also been shown to restore homogeneous myocardial glucose metabolism, without a decrease in myocardial perfusion.6 These findings were mirrored by similar findings regarding the effects of CRT on myocardial perfusion. Resting myocardial blood perfusion was unaltered by CRT despite an increase in left ventricular function. However, the distribution pattern of resting myocardial blood perfusion became more homogeneous, while hyperemic myocardial blood perfusion and myocardial blood perfusion reserve were enhanced by CRT.7 In the long-term, CRT improves morbidity and mortality in adults with heart failure.8, 9
Children have myocardial dysfunction and possibly mechanical dyssynchrony following cardiopulmonary bypass and cardiac surgery. A significant number of children with congenital heart disease have either interventricular conduction delay or right bundle branch block (RBBB). For example, RBBB may occur in patients after ventricular septal defect repair. Others children may develop iatrogenic bundle branch block while requiring ventricular pacing for rate control, hemodynamic improvement or atrioventricular block. When postoperative pacing is indicated, the current method used is to sense or pace the right atrium, depending on the indication, and to pace the right ventricle (univentricular pacing). However, conventional RV univentricular pacing may increase myocardial stress and oxygen utilization through inhomogeneous contraction,10 while long-term right ventricular (univentricular) pacing has been shown in some patients to have detrimental effects on left ventricular remodeling, left ventricular function and clinical outcomes.11-13 Beyond the potential for pacing related myocardial stress and oxygen consumption, the post-operative care of children with congenital heart disease necessitates the use of potent inotropic agents at the expense of increased myocardial oxygen consumption, unwanted effects in the vulnerable post-bypass myocardium.14-16 Preliminary data in children with congenital heart disease undergoing surgical repair have shown acute benefits of CRT as manifested by increased systolic blood pressure and improved cardiac output associated with a reduced QRS duration. These beneficial effects were obtained in children with both single and dual ventricular physiology.17-20 Pham et al showed improvement in cardiac index with biventricular pacing in children after heart surgery, but not with conventional atrioventricular pacing, suggesting that in patients needing pacing in the postoperative period, biventricular pacing is better than conventional pacing, a conclusion previously reached in adults in the setting of cardiomyopathy.21-23 Despite these beneficial immediate hemodynamic effects, and despite preliminary data on the beneficial effects of CRT in children with congenital heart disease,24-26 it is not known whether a longer period of biventricular pacing in the post-operative period following surgery for congenital heart disease is beneficial and whether this intervention can lead to improved clinical outcomes such as reduction of the use of inotropes, time to extubation and length of admission to the critical care unit. To answer these questions, a prospective, randomized trial is needed. The current study would serve as a pilot study for a larger trial in the event of encouraging results.
Hypothesis
Biventricular pacing improves recovery after cardiac surgery with cardiopulmonary bypass in children with congenital heart disease.
Objectives
Study the effects of biventricular pacing on post-operative hemodynamics and clinical outcomes in children after surgery for congenital heart disease.
Design
Randomized, non-blinded, clinical intervention.
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- Biventricular pacing
- Keywords
- Congenital Heart Disease (CHD), Cardiopulmonary Bypass (CPB), Cardiac Index, Hemodynamics, Pediatrics
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biventricular pacingOther
Randomization into one of 3 study arms for acute phase and for extended phase.
Measurement of baseline variables on arrival to CCU. Acute pacing protocol (order of pacing randomized):
- Atrial sensing- right ventricular pacing 10 min.
- 5 min no pacing (washout).
- Atrial sensing - biventricular pacing 10 min.
- 5 min no pacing (washout).
- Intrinsic rhythm
- 5 min no pacing (washout). Start extended phase pacing according to randomization. Measure hemodynamic variables 10 min after start of pacing.
Measure hemodynamic variables 30 min after start of pacing. Pacing hiatus for 60 minutes at 24 hours with measurement of hemodynamics without pacing and after reinitiating pacing.
Stop pacing at 72 hours or after extubation, whichever comes first. For those patients who are extubated before 72 hours: measurements will be taken before extubation and one hour after extubation. Pacing will then be stopped.
| Study group | Role | What they receive |
|---|---|---|
| Biventricular pacing | Experimental | Patients will be randomized pre-operatively to either the pacing group or to the control group. Patients randomized to receive pacing will 1st undergo an acute pacing phase where the order of the pacing mode will be randomized and then will continue to an extended pacing phase of biventricular pacing. Receives: Other: Biventricular pacing |
| Control | No intervention | Controls will receive standard of care treatment consisting of placement of 2 pacing leads (right atrial and right ventricular), monitoring of the study outcomes, monitoring of oxygen consumption and echocardiography, but no pacing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean cardiac index
- Change in mean cardiac index (as measured by the Fick method with respiratory mass spectroscopy for VO2) from baseline to 48 postoperative hours after arrival in the CCCU, recorded every 6 hours up to 72 hours and at each time blood gases sampled.
Measured: Baseline to 72 hours
Secondary outcomes (10)
Composite clinical score
a.Time until first negative fluid balance b.Time until sternal closure c.Time until first planned extubation d.In-hospital death e.Extracorporeal membrane oxygenation
Measured: Baseline to 72 hours
Oxygen consumption
- Oxygen consumption (respiratory mass spectroscopy), measured continuously, recorded every hour for the 1st 24 hours, then every 6 hours and at each blood gas sampling.
Measured: Every hour for 1st 24 hrs and then every 6hours
Intracardiac pressures (RA, LA, CVP, PA)
Intracardiac pressures (RA, LA, CVP, PA) measured continuously, recorded every hour for the 1st 24 hours, then every 6 hours until lines removed.
Measured: Every hour for the 1st 24 hours, then every 6 hours until lines removed
Mean inotrope score
Mean inotrope score recorded every hour for the 1st 24 hours, then every 6 hours.
Measured: every hour for the 1st 24 hours, then every 6 hours
Mean airway pressure
Mean airway pressure recorded every hour for the 1st 24 hours, then every 6 hours (simultaneously with inotrope score)
Measured: every hour for the 1st 24 hours, then every 6 hours
Serum Lactate
Serum lactate over 72 hours, recorded every 6 hours.
Measured: Over 72 hours recorded every 6 hours
Blood pressure
Blood pressure over 72 hours, recorded every hour for the 1st 24 hours and then every 6 hours
Measured: over 72 hours, recorded every hour for the 1st 24 hours and then every 6hours
Length of stay in CCCU
Length of stay in CCCU (recorded in hours).
Measured: Over 72 hours
Electrical dyssynchrony
Electrical dyssynchrony at 48 hours (QRS duration in msec from 6-lead limb ECG).
Measured: Baseline and 48 hours
Echocardiograms
Echocardiograms will be done at baseline (after arrival in CCCU, before pacing) and at 48 hours after arrival to the CCCU to assess mechanical dyssynchrony.
Measured: Baseline and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startDec 2007
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease (CHD)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Friedberg, The Hospital for Sick Children
- Investigators
- Mark K Friedberg, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806245
- Sponsor's protocol ID
- 1000010911
- Status last verified
- Oct 2017
- First submitted
- 16 Jun 2016
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Friedberg MK, Schwartz SM, Zhang H, Chiu-Man C, Manlhiot C, Ilina MV, Arsdell GV, Kirsh JA, McCrindle BW, Stephenson EA. Hemodynamic effects of sustained postoperative cardiac resynchronization therapy in infants after repair of congenital heart disease: Results of a randomized clinical trial. Heart Rhythm. 2017 Feb;14(2):240-247. doi: 10.1016/j.hrthm.2016.09.025. Epub 2016 Sep 26.
PubMed 27687644
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biventricular Pacing in Children After Surgery for Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02806245
- Acronym / sponsor ID
- 1000010911
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- Congenital Heart Disease (CHD), Cardiopulmonary Bypass (CPB), Cardiac Index, Hemodynamics, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Jun 2016 (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.
Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased and emphasis has shifted to post-operative morbidity and recovery. Children with CHD undergoing surgery with CPB can experience well-characterized post-operative cardiac dysfunction. When severe, patients can develop clinically important low cardiac output syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise is primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine, which affect the strength of the heart's muscular contractions. These are used to maintain adequate blood pressure (BP) and CI. However, inotropic agents are potentially detrimental to myocardial function and may increase risk for post-operative arrhythmia and impair post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2). In combination with the increased VO2 associated with CPB-induced systemic inflammatory response patients can develop a critical mismatch between oxygen supply and demand, essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic stability without increased VO2 are beneficial. This study will test whether BiVp, a specialized yet simple pacing technique, can improve post-operative CI and recovery in infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study hypothesizes that Continuous BiVp increases the mean change in CI from baseline to 72 hours in infants with EMD following CHD surgery compared to standard care alone.
Detailed description
In adults with heart failure with intrinsic or iatrogenic left bundle branch block (eg, RV pacing), and more recently in those with narrow QRS complex, pacing the heart with advanced pacing techniques from both the left and right ventricle (LV, RV) termed cardiac resynchronization therapy (CRT) improves resting systolic heart function and mechanoenergetics.1 In these patients, CRT has been shown to increase LV stroke volume, ejection fraction, and stroke work, resulting in an enhancement of LV myocardial efficiency, without an increase in oxidative metabolism and even a decrease in energy utilization.2-4 Furthermore, oxygen consumption seems to be distributed more homogeneously during CRT.2 Beyond increasing resting myocardial efficiency, CRT may increase metabolic reserve as judged by the increase in cardiac work in response to dobutamine.5 CRT has also been shown to restore homogeneous myocardial glucose metabolism, without a decrease in myocardial perfusion.6 These findings were mirrored by similar findings regarding the effects of CRT on myocardial perfusion. Resting myocardial blood perfusion was unaltered by CRT despite an increase in left ventricular function. However, the distribution pattern of resting myocardial blood perfusion became more homogeneous, while hyperemic myocardial blood perfusion and myocardial blood perfusion reserve were enhanced by CRT.7 In the long-term, CRT improves morbidity and mortality in adults with heart failure.8, 9
Children have myocardial dysfunction and possibly mechanical dyssynchrony following cardiopulmonary bypass and cardiac surgery. A significant number of children with congenital heart disease have either interventricular conduction delay or right bundle branch block (RBBB). For example, RBBB may occur in patients after ventricular septal defect repair. Others children may develop iatrogenic bundle branch block while requiring ventricular pacing for rate control, hemodynamic improvement or atrioventricular block. When postoperative pacing is indicated, the current method used is to sense or pace the right atrium, depending on the indication, and to pace the right ventricle (univentricular pacing). However, conventional RV univentricular pacing may increase myocardial stress and oxygen utilization through inhomogeneous contraction,10 while long-term right ventricular (univentricular) pacing has been shown in some patients to have detrimental effects on left ventricular remodeling, left ventricular function and clinical outcomes.11-13 Beyond the potential for pacing related myocardial stress and oxygen consumption, the post-operative care of children with congenital heart disease necessitates the use of potent inotropic agents at the expense of increased myocardial oxygen consumption, unwanted effects in the vulnerable post-bypass myocardium.14-16 Preliminary data in children with congenital heart disease undergoing surgical repair have shown acute benefits of CRT as manifested by increased systolic blood pressure and improved cardiac output associated with a reduced QRS duration. These beneficial effects were obtained in children with both single and dual ventricular physiology.17-20 Pham et al showed improvement in cardiac index with biventricular pacing in children after heart surgery, but not with conventional atrioventricular pacing, suggesting that in patients needing pacing in the postoperative period, biventricular pacing is better than conventional pacing, a conclusion previously reached in adults in the setting of cardiomyopathy.21-23 Despite these beneficial immediate hemodynamic effects, and despite preliminary data on the beneficial effects of CRT in children with congenital heart disease,24-26 it is not known whether a longer period of biventricular pacing in the post-operative period following surgery for congenital heart disease is beneficial and whether this intervention can lead to improved clinical outcomes such as reduction of the use of inotropes, time to extubation and length of admission to the critical care unit. To answer these questions, a prospective, randomized trial is needed. The current study would serve as a pilot study for a larger trial in the event of encouraging results.
Hypothesis
Biventricular pacing improves recovery after cardiac surgery with cardiopulmonary bypass in children with congenital heart disease.
Objectives
Study the effects of biventricular pacing on post-operative hemodynamics and clinical outcomes in children after surgery for congenital heart disease.
Design
Randomized, non-blinded, clinical intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biventricular pacing | Experimental | Other: Biventricular pacingPatients will be randomized pre-operatively to either the pacing group or to the control group. Patients randomized to receive pacing will 1st undergo an acute pacing phase where the order of the pacing mode will be randomized and then will continue to an extended pacing phase of biventricular pacing. |
| Control | No intervention | –Controls will receive standard of care treatment consisting of placement of 2 pacing leads (right atrial and right ventricular), monitoring of the study outcomes, monitoring of oxygen consumption and echocardiography, but no pacing. |
Who may qualify
- Ages
- 1 day to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- < 4 months of age at time of surgery
- Surgery for congenital heart disease requiring cardiopulmonary bypass
- Reparative surgery to achieve biventricular cardiac physiology.
- Sinus rhythm.
Key exclusion criteria (10 listed)
- Isolated atrial septal defect repair.
- Surgery without cardiopulmonary bypass.
- Palliative surgery.
- Single ventricle physiology.
- Age > 4 months at time of surgery
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 |
|---|---|---|
| Biventricular pacingRandomization into one of 3 study arms for acute phase and for extended phase. Measurement of baseline variables on arrival to CCU. Acute pacing protocol (order of pacing randomized): 1. Atrial sensing- right ventricular pacing 10 min. 2. 5 min no pacing (washout). 3. Atrial sensing - biventricular pacing 10 min. 4. 5 min no pacing (washout). 5. Intrinsic rhythm 6. 5 min no pacing (washout). Start extended phase pacing according to randomization. Measure hemodynamic variables 10 min after start of pacing. Measure hemodynamic variables 30 min after start of pacing. Pacing hiatus for 60 minutes at 24 hours with measurement of hemodynamics without pacing and after reinitiating pacing. Stop pacing at 72 hours or after extubation, whichever comes first. For those patients who are extubated before 72 hours: measurements will be taken before extubation and one hour after extubation. Pacing will then be stopped. | Other | Biventricular pacing |
Primary outcome
Change in mean cardiac index
Time frame: Baseline to 72 hours
1. Change in mean cardiac index (as measured by the Fick method with respiratory mass spectroscopy for VO2) from baseline to 48 postoperative hours after arrival in the CCCU, recorded every 6 hours up to 72 hours and at each time blood gases sampled.
10 secondary outcomes
Composite clinical score
Time frame: Baseline to 72 hours
Oxygen consumption
Time frame: Every hour for 1st 24 hrs and then every 6hours
Intracardiac pressures (RA, LA, CVP, PA)
Time frame: Every hour for the 1st 24 hours, then every 6 hours until lines removed
Mean inotrope score
Time frame: every hour for the 1st 24 hours, then every 6 hours
Mean airway pressure
Time frame: every hour for the 1st 24 hours, then every 6 hours
Serum Lactate
Time frame: Over 72 hours recorded every 6 hours
Blood pressure
Time frame: over 72 hours, recorded every hour for the 1st 24 hours and then every 6hours
Length of stay in CCCU
Time frame: Over 72 hours
Electrical dyssynchrony
Time frame: Baseline and 48 hours
Echocardiograms
Time frame: Baseline and 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Results publication: PubMed 27687644Friedberg MK, Schwartz SM, Zhang H, Chiu-Man C, Manlhiot C, Ilina MV, Arsdell GV, Kirsh JA, McCrindle BW, Stephenson EA. Hemodynamic effects of sustained postoperative cardiac resynchronization therapy in infants after repair of congenital heart disease: Results of a randomized clinical trial. Heart Rhythm. 2017 Feb;14(2):240-247. doi: 10.1016/j.hrthm.2016.09.025. Epub 2016 Sep 26.
- Individual participant dataSharing planned: Undecided
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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.
Mark K Friedberg, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biventricular pacing in people with Congenital Heart Disease (CHD), run by The Hospital for Sick Children at 1 site 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 12 Oct 2017. 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in mean cardiac index (time frame: Baseline to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02806245, which also lists 1 linked publication.
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 12 Oct 2017.