Cardiac Output, LowPhase 2CortiNCT00590018
Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease
A Phase 2 study testing Hydrocortisone in people with Cardiac Output, Low, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Babies having heart surgery often have problems after surgery with their blood pressure and getting enough blood to their bodies. To treat this they require medicines to keep their blood pressure high enough to get blood to their bodies. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Cardiac Output, Low
- What is being tested?
- Hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age < 1 month
- Postoperative
- Inotrope score > 20 x > 4 hrs [epinephrine: (mcg/kg/min) x 100 + norepinephrine: (mcg/kg/min) x 100 + phenylephrine: (mcg/kg/min) x 100 + vasopressin: (units/kg/hr) x 100 + milrinone: (mcg/kg/min) x 15 + dopamine: (mcg/kg/min) x 1 + dobutamine: (mcg/kg/min) x 1 + calcium chloride: (mg/kg/hr) x 1]
Who cannot join
- Age > 1 month
- Documented sepsis
- Preoperative use of steroids > 1 wk
Trial locations and contacts
1 site in 1 country.
About this study
Babies having heart surgery often have problems after surgery with their blood pressure and getting enough blood to their bodies. To treat this they require medicines to keep their blood pressure high enough to get blood to their bodies. The side effects of these medicines include fast heart rates and increasing the amount of work the heart has to do. Corticosteroids are made by the body and help to use the energy in the food people eat, control the chemicals in their blood and maintain their blood pressure. Corticosteroids made by the body may be decreased in patients that have major surgery. Corticosteroids help to increase blood pressure and can decrease the amount of blood pressure medicines a patient requires. Corticosteroids have been shown to increase blood pressure in patients with bacterial infections and in very small, premature babies but have only been studied in a few babies who have had heart surgery. The way corticosteroids work is unknown but may involve decreasing the body's response to being on a heart-lung machine or give steroids not being made by the patient.
Corticosteroids have been shown to be helpful in treating many diseases. The purpose of this study is to look at the effects of corticosteroids in babies who have had heart surgery and need blood pressure medicines in the intensive care unit after surgery. Our idea is that getting corticosteroids will allow us to decrease the amount of blood pressure medicines each patient needs and improve how they do after surgery. We also plan to do blood tests to help determine how the corticosteroids are working.
It will be randomly determined if the subject receives corticosteroids or salt water. The subject will receive a corticosteroid or salt water once a day for five days. Their vital signs will be monitored, especially blood pressure and their need for medicines to increase their blood pressure. Blood work will also be obtained to determine their body's ability to make steroids.
Read the detailed description
The study will be prospective. Patients who meet entry criteria will be randomized to receive corticosteroids versus placebo. Randomization will take into account biventricular versus univentricular repairs/palliations and whether the patients received intraoperative steroids. Patients will be compared with matched controls based on: diagnosis, +/- intraoperative steroids/phenoxybenzamine, cardiopulmonary bypass/cross clamp/circulatory arrest times and inotrope requirements. Those in the treatment arm will be dosed with hydrocortisone - stress dose (100mg/m2/dose daily x2, then taper with two days at half the original dose and one day at one quarter of the original dose) and then the steroids will be discontinued. Outcome data will include: heart rate, blood pressure, mixed venous oxygen saturation to assess cardiac output, blood cultures/infection/antibiotics (antibiotics as deemed necessary by the primary cardiologist), +/- gastrointestinal bleeding, time to discontinuing inotropic agents, time to extubation, length of intensive care unit admission and survival. Laboratory studies will be assessed before and 24 hours after the institution of steroids. The following labs are standard of care in the unit and will be assessed: glucose, electrolytes, blood urea nitrogen/creatinine, complete blood counts, lactate, arterial blood gases, cultures and stool guaiac. The following labs will be assessed in addition to regular monitoring: cortisol, adrenocorticotropin hormone and C reactive protein.
- Conditions
- Cardiac Output, Low
- Being tested
- Hydrocortisone, Placebo
- Keywords
- Congenital heart disease., Low cardiac output syndrome., Corticosteroids., Hydrocortisone., Blood pressure., Inotropes.
- Medical subject headings
- Cardiac Output, Low, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called Corticosteroids., Steroids.
Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
PlaceboDrug
Placebo for 5 days intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Receives: Drug: Hydrocortisone |
| 2 | Placebo comparator | Subjects in this arm will receive 5 days of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure.
Change in mean blood pressure recorded prior to (15 minutes prior to study drug) and subsequent to medication/placebo administration (at 2 days post drug administration).
Measured: 2 days
Secondary outcomes (1)
Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration.
Inotrope score: epinephrine (mcg/kg/min x 100) + norepinephrine (mcg/kg/min x 100) + phenylephrine (mcg/kg/min x 100) + dopamine (mcg/kg/min x1) + dobutamine (mcg/kg/min x 1) + milrinone (mcg/kg/min x15). A lower inotrope score is better with the minimum being 0 and the maximum being 85.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startFeb 2003
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Dickerson, Baylor College of Medicine
- Investigators
- Heather A Dickerson, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590018
- Sponsor's protocol ID
- H-12030
- Acronym
- Corti
- Status last verified
- Apr 2016
- First submitted
- 28 Dec 2007
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Suominen PK, Dickerson HA, Moffett BS, Ranta SO, Mott AR, Price JF, Heinle JS, McKenzie ED, Fraser CD Jr, Chang AC. Hemodynamic effects of rescue protocol hydrocortisone in neonates with low cardiac output syndrome after cardiac surgery. Pediatr Crit Care Med. 2005 Nov;6(6):655-9. doi: 10.1097/01.pcc.0000185487.69215.29.
PubMed 16276331Gibbison B, Villalobos Lizardi JC, Aviles Martinez KI, Fudulu DP, Medina Andrade MA, Perez-Gaxiola G, Schadenberg AW, Stoica SC, Lightman SL, Angelini GD, Reeves BC. Prophylactic corticosteroids for paediatric heart surgery with cardiopulmonary bypass. Cochrane Database Syst Rev. 2020 Oct 12;10(10):CD013101. doi: 10.1002/14651858.CD013101.pub2.
PubMed 33045104
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT00590018
- Acronym / sponsor ID
- Corti / H-12030
- Conditions
- Cardiac Output, Low
- Keywords
- Congenital heart disease., Low cardiac output syndrome., Corticosteroids., Hydrocortisone., Blood pressure., Inotropes.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Posted 26 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Babies having heart surgery often have problems after surgery with their blood pressure and getting enough blood to their bodies. To treat this they require medicines to keep their blood pressure high enough to get blood to their bodies. The side effects of these medicines include fast heart rates and increasing the amount of work the heart has to do. Corticosteroids are made by the body and help to use the energy in the food people eat, control the chemicals in their blood and maintain their blood pressure. Corticosteroids made by the body may be decreased in patients that have major surgery. Corticosteroids help to increase blood pressure and can decrease the amount of blood pressure medicines a patient requires. Corticosteroids have been shown to increase blood pressure in patients with bacterial infections and in very small, premature babies but have only been studied in a few babies who have had heart surgery. The way corticosteroids work is unknown but may involve decreasing the body's response to being on a heart-lung machine or give steroids not being made by the patient.
Corticosteroids have been shown to be helpful in treating many diseases. The purpose of this study is to look at the effects of corticosteroids in babies who have had heart surgery and need blood pressure medicines in the intensive care unit after surgery. Our idea is that getting corticosteroids will allow us to decrease the amount of blood pressure medicines each patient needs and improve how they do after surgery. We also plan to do blood tests to help determine how the corticosteroids are working.
It will be randomly determined if the subject receives corticosteroids or salt water. The subject will receive a corticosteroid or salt water once a day for five days. Their vital signs will be monitored, especially blood pressure and their need for medicines to increase their blood pressure. Blood work will also be obtained to determine their body's ability to make steroids.
Detailed description
The study will be prospective. Patients who meet entry criteria will be randomized to receive corticosteroids versus placebo. Randomization will take into account biventricular versus univentricular repairs/palliations and whether the patients received intraoperative steroids. Patients will be compared with matched controls based on: diagnosis, +/- intraoperative steroids/phenoxybenzamine, cardiopulmonary bypass/cross clamp/circulatory arrest times and inotrope requirements. Those in the treatment arm will be dosed with hydrocortisone - stress dose (100mg/m2/dose daily x2, then taper with two days at half the original dose and one day at one quarter of the original dose) and then the steroids will be discontinued. Outcome data will include: heart rate, blood pressure, mixed venous oxygen saturation to assess cardiac output, blood cultures/infection/antibiotics (antibiotics as deemed necessary by the primary cardiologist), +/- gastrointestinal bleeding, time to discontinuing inotropic agents, time to extubation, length of intensive care unit admission and survival. Laboratory studies will be assessed before and 24 hours after the institution of steroids. The following labs are standard of care in the unit and will be assessed: glucose, electrolytes, blood urea nitrogen/creatinine, complete blood counts, lactate, arterial blood gases, cultures and stool guaiac. The following labs will be assessed in addition to regular monitoring: cortisol, adrenocorticotropin hormone and C reactive protein.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HydrocortisoneSubjects in this arm will receive a 5 day tapering course of hydrocortisone. |
| 2 | Placebo comparator | Drug: PlaceboSubjects in this arm will receive 5 days of placebo. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age < 1 month
- Postoperative
- Inotrope score > 20 x > 4 hrs [epinephrine: (mcg/kg/min) x 100 + norepinephrine: (mcg/kg/min) x 100 + phenylephrine: (mcg/kg/min) x 100 + vasopressin: (units/kg/hr) x 100 + milrinone: (mcg/kg/min) x 15 + dopamine: (mcg/kg/min) x 1 + dobutamine: (mcg/kg/min) x 1 + calcium chloride: (mg/kg/hr) x 1]
Key exclusion criteria (3 listed)
- Age > 1 month
- Documented sepsis
- Preoperative use of steroids > 1 wk
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 |
|---|---|---|
| HydrocortisoneAlso: Corticosteroids., Steroids.Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously. | Drug | 1 |
| PlaceboPlacebo for 5 days intravenously. | Drug | 2 |
Primary outcome
Blood Pressure.
Time frame: 2 days
Change in mean blood pressure recorded prior to (15 minutes prior to study drug) and subsequent to medication/placebo administration (at 2 days post drug administration).
1 secondary outcome
Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration.
Time frame: 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16276331Suominen PK, Dickerson HA, Moffett BS, Ranta SO, Mott AR, Price JF, Heinle JS, McKenzie ED, Fraser CD Jr, Chang AC. Hemodynamic effects of rescue protocol hydrocortisone in neonates with low cardiac output syndrome after cardiac surgery. Pediatr Crit Care Med. 2005 Nov;6(6):655-9. doi: 10.1097/01.pcc.0000185487.69215.29.
- Derived from this study: PubMed 33045104Gibbison B, Villalobos Lizardi JC, Aviles Martinez KI, Fudulu DP, Medina Andrade MA, Perez-Gaxiola G, Schadenberg AW, Stoica SC, Lightman SL, Angelini GD, Reeves BC. Prophylactic corticosteroids for paediatric heart surgery with cardiopulmonary bypass. Cochrane Database Syst Rev. 2020 Oct 12;10(10):CD013101. doi: 10.1002/14651858.CD013101.pub2.
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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.
Heather A Dickerson, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrocortisone in people with Cardiac Output, Low, run by Baylor College of Medicine at 1 site in United States.
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 3 inclusion and 3 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 26 May 2016. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Pressure. (time frame: 2 days). 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 NCT00590018, which also lists 2 linked publications.
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 26 May 2016.