Lactate Levels During Cardiopulmonary Bypass in Pediatric Patients

NCT02618707 | Completed DMC

• 1 other identifier: IRB0000871120
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Many variables measured in critically ill patients have been used to estimate severity of disease, prognosticate morbidity and mortality, evaluate costs of treatment, and finally indicate specific treatment and monitor the adequacy of treatment and its timing. It is unlikely that one measurement can replace all of these, but in the remainder of this manuscript the investigators will show that lactate levels may come close. Although in our mind strongly linked to tissue hypoxia, lactate levels follow many more metabolic processes not related to tissue hypoxia and, therefore, subject to many disturbances found in various clinical situations

Conditions

Heart Defects, Congenital

Keywords

Lactate; Congenital cardiac defect; CPB; Pediatric

Outcome Measures

Primary Outcomes (1)

• Serum lactate during CPB

  lactate value (mmol/L)

  first 24 hours

Study Arms (1)

Lactate

Lactate samples will drawn at specific time points within 5 time intervals: before CPB after induction, during cooling on CPB, during rewarming on CPB, immediately after CPB in the operating room, and after admission to the post-operative intensive care unit.

Other: Lactate

Interventions

Lactate OTHER

Lactate samples will drawn at specific time points within 5 time intervals: before CPB after induction, during cooling on CPB, during rewarming on CPB, immediately after CPB in the operating room, and after admission to the post-operative intensive care unit.

Lactate

Eligibility Criteria

• Age: 12 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

cardiac surgery for children with congenital heart defects

You may qualify if:

• age range (1-12 years)
• Usage of cardiopulmonary bypass

You may not qualify if:

• chest problems
• Renal problems
• Hepatic problems

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Asyut Governorate, 74111, Egypt

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Lactic Acid

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Study Officials

• sayed abd elshafy, MD

  associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Study Record Dates

• First Submitted: November 21, 2015
• First Posted: December 1, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 7, 2016

Record last verified: 2016-03

Locations

EG (1)