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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 July 2024 |
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Main ID: |
NCT05521152 |
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Date of registration:
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28/08/2022 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy
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Scientific title:
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Prophylactic Use of Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy Operation for Biliary Atresia: Double Blinded Randomized Controlled Trial |
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Date of first enrolment:
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August 28, 2022 |
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Target sample size:
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31 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT05521152 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Khaled Sarhan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University Hospitals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infants, ASA III, diagnosed as biliary atresia undergoing Kasai operation.
Exclusion Criteria:
- Parents refusal. Patients with complex cardiac anomalies. Patients requiring
emergency or laparoscopic procedures.
Age minimum:
1 Month
Age maximum:
4 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Biliary Atresia
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Anesthesia
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Pediatrics
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Intervention(s)
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Drug: Placebo
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Drug: Norepinephrine Bitartrate
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Primary Outcome(s)
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Incidence of intraoperative hypotension
[Time Frame: 4 hours]
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Secondary Outcome(s)
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Incidence of hypertension
[Time Frame: 4 hours]
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mean arterial pressure (MAP)
[Time Frame: 4 hours]
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Total dose of rescue norepinephrine.
[Time Frame: 4 hours]
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Incidence of severe hypotension
[Time Frame: 4 hours]
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heart rate
[Time Frame: 4 hours]
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Secondary ID(s)
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MD-12-2021
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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