Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery

NCT ID: NCT06292910

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-08

Study Completion Date

2023-12-26

Brief Summary

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The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial.

The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research

Detailed Description

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Conditions

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Congenital Heart Disease Perioperative/Postoperative Complications Lactate Blood Increase

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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arterial and central venous blood gas analysis, lactate

blood gas analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Children aged 0-18 years old with either congenital or acquired cardiac disease
* Undergone cardiopulmonary bypass for cardiac surgery
* Be admitted in PICU for post-operative care

Exclusion Criteria

* Preterm infant (GA \< 37 weeks) or weight less than 2 kg
* Patient who weaned off cardiopulmoanry bypass and required extracorporeal membrane oxygenator (ECMO) before leaving the operating room
* Patient who required emergency cardiac operation within 24 hour after hospitalization
* Patient who had significant residual left side outflow tract obstruction (e.g., coarctation of aorta, interrupted aortic arch) which defined by difference of SBP between upper and lower extremities more than 10 mmHg
* Patient who had already participated in another research project
* Patient who does not have both arterial line and central line catheter back from operating room
* Parents or legal guardian refuse to inform consent.
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Pharsai Prasertsan

Assist. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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REC 64-299-1-1

Identifier Type: -

Identifier Source: org_study_id

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