Clinical trial

Dobutamine Versus Milrinone in Management of Critically Ill Low Cardiac Output Pediatric Patients at Cairo University Children's Hospital

Name

inotropes in pediatrics

Description

The aim of the study is to detect wither dobutamine or milrinone have a privilege in the management of low cardiac output pediatric patients over the other.

Trial arms

Trial start

2023-10-01

Estimated PCD

2024-03-01

Trial end

2024-05-01

Status

Not yet recruiting

Treatment

Dobutamine

Patient randomization will be done by a computer based generation , serial enveloped numbers will be taken for the patients. Cardiac assessment will be done by a blinded pediatric cardiologist. If at any time the randomly assigned therapy considered to be failed or unsafe to continue, the treating physician will discontinue randomization and will continue with the appropriate medication according to the patients need. Milrinone will start by 0.25 , 0.5 , 0.75 we can titrate up with time interval 3 hours after re-assessment. Dobutamine will start by 5, 10 , 15, 20 we can titrate with time interval 15 mins after re-assesment.

Arms:

patients who will recieve dobutrex, patients who will recieve milirinone

Other names:

milrinone

Size

Primary endpoint

time to achievemnets of theraputeic endpoints of hemodynamics

first 24 hrs

Eligibility criteria

Inclusion Criteria: * 1-Patients from age of 1 month to 14 years old of both sexes. 2-Patients presenting with fluid refractory shock with low cardiac output state, evidenced by sustained hypotension (systolic blood pressure below 5th percentile for age) and end organ dysfunction (altered level of consciousness, renal or hepatic dysfunction) 3-Clinical evidence of systemic and/or pulmonary congestion despite use of vasodilators and/or diuretics 4-Refractory heart failure requiring admission for inotropic support. Exclusion Criteria: 1-All other causes of pediatric shock not in need for inotropic support (eg.isolated hypovolemic shock, anaphylaxis,....) 2 - patients not fit for randomization needing specific line of management (eg. Sever hypotension patients with good filling pressure unfit for milrinone , patients previously known having sever pulmonary hypertension not fit for dobutamine ,...) 3-post cardiac surgery patients with low cardiac output manifestation.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '. Cardiac assessment will be done by a blinded pediatric cardiologist.', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2023-08-21

1 organization

1 product

4 indications

Organization

Product

Indication

Indication

Indication

Indication