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

NCT06292910 | Completed DMC

• 1 other identifier: REC 64-299-1-1
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Heart Disease; Perioperative/Postoperative Complications; Lactate Blood Increase

Outcome Measures

Primary Outcomes (1)

• number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation

  the low cardiac output syndrome (LCOS) related poor outcomes was diagnosed if at least two of the following criteria were met within 24 hours postoperatively: 1. clinical LCOS: prolonged capillary refill \>3 seconds, systolic blood pressure \<5th percentile for age and sex, persistent elevation of left atrial pressure \>10 mmHg for at least 6 hours, and low urinary output (\<1 mL/kg/hour) for at least 6 hours despite diuretic use 2. laboratory LCOS: persistently elevated lactate level (\>2 mmol/L), metabolic acidosis with an increase in the base deficit (\>4 mmol/L) for at least 6 hours consecutively 3. Vasoactive-inotropic score ≥20 4. any unplanned surgery or intervention, cardiac arrest, or utilization of ECMO 5. left ventricular fraction \<50% on echocardiography

  from time of subject was admitted to ICU until the 24 hour post operation

Secondary Outcomes (3)

• ventilator days

  from date of subject was admitted to ICU until the date of subject was extubated, assessed up to 28 days

• inotrope days

  from date of subject was admitted to ICU until the date of subject was free of inotropic drugs, assessed up to 28 days

• length of stay in ICU

  from date of subject was admitted to ICU until the date of subject was discharge, assessed up to 28 days

Interventions

arterial and central venous blood gas analysis, lactate DIAGNOSTIC_TEST

blood gas analysis

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with cardiac disease in Songklanagarind hospital who undergone open cardiac surgery with cardiopulmonary bypass (age \< 18 years old)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Postoperative Complications; Hyperlactatemia

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: March 5, 2024
• Study Start: August 8, 2021
• Primary Completion: December 21, 2023
• Study Completion: December 26, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-02

Locations

TH (1)