Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202104905893217 Date of Approval: 12/04/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Prognostic Value of Combined Central Venous Oxygen Saturation and Lactate in Pediatrics Following Cardiac Surgery.
Official scientific title Prognostic Value of Combined Central Venous Oxygen Saturation and Lactate in Pediatrics Following Cardiac Surgery.
Brief summary describing the background and objectives of the trial Identification of predictors of morbidity and mortality is an important issue for the optimal management of patients with cardiac pathologies in the intensive care unit (ICU). It is now well accepted that macrohemodynamic assessment may fail to detect persistent tissue hypoxia, as reflected by increased lactate levels and low central venous oxygen saturation (ScvO2), in a wide range of clinical conditions. Central venous oxygen saturation (ScvO2) and lactate levels have been utilized widely in critical care to identify patients with occult hypoperfusion and as resuscitation endpoints. Unlike septic patients, patients undergoing cardiovascular surgery usually have brief postoperative ICU and hospital lengths of stay (LOS). However, about 10% of these patients undergo prolonged care due to organ failure as the fundamental contributor. Moreover, Global tissue hypoxia (GTH) after cardiac surgery has been associated with a prolonged ICU course. Abnormal lactate and ScvO2 values obtained immediately after surgery have been found to detect cryptic shock, and elevated lactate and low ScvO2 have been associated independently with an increased risk of complications after cardiac surgery and in high-risk general surgical patients, respectively. A number of studies have examined the relationship between low ScvO2 or elevated lactate levels and morbidity/mortality in high-risk general surgery and cardiac surgery patients. Most have examined ScvO2 or lactate individually rather than in combination With the exception of one study in adults which found the combination of low ScvO2 and elevated lactate to be associated with worse outcomes. There have been no studies in pediatrics addressing the combined use of ScvO2 and lactate upon (ICU) admission as predictors of outcome after cardiac surgery. The present study investigates the hypothesis that simultaneous measurement of ScvO2 coupled with serial blood lactate determination may provide one or more early markers for postoperative
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 17/04/2021
Actual trial start date 17/04/2021
Anticipated date of last follow up 31/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Venous Oxygen saturation 24 hours 0.2 ml taken from venous blood for venous blood gases at 0-3-6-12-18-24 hours after admission of the patient to PICU from OR 35
Control Group Arterial serum lactate 24 hours 0.2 ml taken from Arterial blood for Arterial blood gases at 0-3-6-12-18-24 hours after admission of the patient to PICU from OR 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
On-pump & off-pump cardiac operation. The presence of a central venous catheter in the internal jugular position available after surgery. - Intraoperative cardiac arrest - Massive perioperative bleeding - Presence of a PA catheter - Use of extracorporeal membrane oxygenation (ECMO) on ICU arrival - Presence of a ventricular assist device (VAD) - Pre‑existing congestive cardiac failure, cardiomyopathy, hemodynamic instability, arrest or need of inotropic support before the operation - Elevation of any parameters preoperatively indicating systemic hypoperfusion, coagulopathy, renal failure (serum creatinine >2 mg/dl, anuria, or oliguria requiring dialysis), hepatic dysfunction (aspartate aminotransferase >40 U/L, alanine aminotransferase >40 U/L) immediately before surgery - Local or systemic infection or inflammation (fever, leukocytosis, tachycardia, or tachypnea, white blood cell count >12,000 cells/mm3, or platelet count <100,000 cells/mm3) immediately before surgery - Reoperation Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 1 Day(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/08/2020 Menoufia University Faculty of Medicine Research Ethics Committee IRB No. PEDI 27
Ethics Committee Address
Street address City Postal code Country
Gamal Abd El-Nasir, Qism Shebeen El-Kom, Shibin el Kom, Menofia Governorate Shibin el Kom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome In-hospital mortality. in hospital stay till discharge
Primary Outcome Major complications (infection, sepsis, stroke, pulmonary embolism, prolonged mechanical ventilation, and renal failure) in hospital stay till discharge
Secondary Outcome ICU length of stay LOS till discharge from ICU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aswan Heart Centre Kasr El Haggar Aswan 81528 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alaa Atef Hegazy 4 Nor Al Islam Street off El Safa street, Stadium area Tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Facullty of medicine Menofia University El-Ghazaly, Qism Shebeen El-Kom, Shibin el Kom, Menofia Governorate Shibin el Kom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fady El Gendy Imam Street off Sharaf square Shibin el Kom Shibin el Kom 32511 Egypt
Alyaa AbdElAziz 8 Mohammed Awad Alla Miami Alexandria 21500 Egypt
Alaa Atef Hegazy 4 Nor Al Islam Street off El Safa street, Stadium area Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alyaa AbdElAziz dr.alyaa3000@gmail.com 00201090190865 8 Mohammed AwadAlla, Miami
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt Lecturer of Pediatrics Faculty Of Medicine Menofia University Menoufia Egypt
Role Name Email Phone Street address
Scientific Enquiries Fady El Gendy fady.elgendy@yahoo.com 00201005169008 El-Ghazaly, Qism Shebeen El-Kom, Shibin el Kom, Menofia Governorate
City Postal code Country Position/Affiliation
Shibin El Koum 32511 Egypt Professor of Pediatrics Faculty Of Medicine Menofia University Menoufia Egypt
Role Name Email Phone Street address
Public Enquiries Alyaa Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information