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.: PACTR202010510238366 Date of Approval: 26/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of vasopressors on resting energy expenditure in critically ill mechanically ventilated patients measured via indirect calorimetry
Official scientific title The effect of vasopressors on resting energy expenditure in critically ill mechanically ventilated patients measured via indirect calorimetry
Brief summary describing the background and objectives of the trial Indirect calorimetry (IC) is considered as the gold standard for measuring resting energy expenditure (REE) in the critically ill patient. The use of predictive equations for estimation of energy expenditure, to develop nutrition regimens, can be problematic in the critical care setting, due to the unpredictable effects of disease, injury, and stress on REE The aim of this study was to examine the effect of noradrenaline on REE measured by indirect calorimetry (IC). Also, we aimed to compare the REE measured via indirect calorimetry and REE calculated by the Harris-Benedict equation.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/07/2018
Actual trial start date 01/07/2018
Anticipated date of last follow up 01/12/2018
Actual Last follow-up date 01/12/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mechanical ventilation with indirect calirometry At least 60 min the patient lying supine and ventilator settings left unchanged for at least 60 minutes ahead of indirect calorimetry. 20
Control Group Mechanical ventilation The Harris Benedict equation for prediction of energy expenditure was also ca 60 min the patient lying supine and ventilator settings left unchanged for at least 60 minutes.The Harris Benedict equation for prediction of energy expenditure was also calculated. 20 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients included in the study were aged between 18 and 60 years and who were clinically suspected of having severe sepsis defined by the criteria of the American College of Chest Physicians/ Society of Critical Care Medicine Consensus Conference; (12) and received noradrenaline vasopressor therapy. Exclusion criteria included patients aged less than 18 years and more than 60-years-old, pregnant patients, patients who required chest tube insertion, patients who received an FiO2 more than 0.6 and PEEP more than 14 cm H2O, patients with body temperature more than 38oC or less than 36 oC, acute hepatitis or severe liver disease (Child-Pugh class C), patients on haemodialysis and patients with known endocrine dysfunction as myxedema, thyrotoxicosis, Addison’s disease and Cushing syndrome. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 15/04/2018 Cairo university
Ethics Committee Address
Street address City Postal code Country
Almanial st cairo egypt Cairo 16140 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome primary outcome of the study was the correlation between the change in vasopressor concentration and the REE measured by indirect calorimetry 5
Secondary Outcome The secondary outcome was the correlation between REE measured by indirect calorimetry and REE calculated by Harris Benedict equation 5
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr alainy Elmanial st cairo egypt Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kasr alainy Elmanial st cairo Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Zaghloul A_zaghloul2000@yahoo.com 01001839591 5 Nasr st haram
City Postal code Country Position/Affiliation
Giza Egypt Assitant professor
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Badry Mahmoud_badry2000@yahoo.con 01001844291 55tersast
City Postal code Country Position/Affiliation
Giza Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Yassmin Elbasha yasmin.saad.basha@gmail.com 01004523789 Haram st giza
City Postal code Country Position/Affiliation
Giza Egypt Assistant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes This Prospective observational study was conducted in the surgical ICU, Cairo University Hospitals on all mechanically ventilated patients in the period from July 2016 to December 2016. The study protocol was approved by the Research Ethics Committee and informed consent will be obtained from patients’ next-of-kin prior to commencemen Informed Consent Form,Study Protocol This Prospective observational study was conducted in the surgical ICU, Cairo University Hospitals on all mechanically ventilated patients in the period from July 2016 to December 2016. The study protocol was approved by the Research Ethics Committee and informed consent will be obtained from patients’ next-of-kin prior to commencemen Vassopresor mechanical ventilation
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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