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.: PACTR202306581320725 Date of Approval: 08/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The use of End Expiratory Occlusion Test vs. Inferior Vena Cava Respiratory Variation for prediction of volume responsiveness in mechanically ventilated patients with sepsis
Official scientific title The use of End Expiratory Occlusion Test vs. Inferior Vena Cava Respiratory Variation for prediction of volume responsiveness in mechanically ventilated patients with sepsis
Brief summary describing the background and objectives of the trial Sepsis is one of the main leading causes of death in ICU patients. The main target in septic patients is the optimal fluid resuscitation; fluid administration represents a first-line therapeutic intervention for improving cardiac output. However, they should be administered only if there is reasonable chance that cardiac output (COP) will increase in response to overcome generalized vasodilatation and capillary leak, this capillary leak itself may result in exacerbation of tissue edema and worsen septic patients. So, Assessing fluid responsiveness is crucial to the effective resuscitation of critically ill patients.to optimize patients many tests or indices detecting “fluid responsiveness” have been developed for this purpose. The dynamic parameters used in assessment of fluid responsiveness are of promising accuracy of prediction . Of these, the echocardiographic measurement of the respiratory variation in the inferior vena cava (IVC) diameter and the End expiratory occlusion (EEO) test. To our knowledge, there’re no studies comparing EEO with IVC respiratory variation in hypovolemic patients. So, the aim of the study is to use end expiratory occlusion test in comparison to ultrasound guided IVC respiratory variation as an index of fluid responsiveness in septic mechanically ventilated patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Assessment of fluid responsiveness in septic shock patients
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Comparing the accuracy of EEO vs IVC in predicting fluid responsiveness in septic shocked patients
Anticipated trial start date 01/03/2023
Actual trial start date 01/03/2023
Anticipated date of last follow up 01/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
FWA 00017585 research ethics committee, faculty of medicine, Ainshams university
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 Randomised Simple randomization using a randomization table created by a computer software program 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 EEO once 15 secs consists in interrupting the ventilator at end-expiration for 15 seconds 34
Experimental Group IVC respiratory variation once time consumed for using ultrasound to assess the right atrial pressure of patients applying the ultrasound to detect the IVC diameter variation according to the following equation (D max - D min )/[(D max + D min )/2] 34
Control Group VTI after Fluid therapy 30 mL/kg of intravenous crystalloid within 3 hours once 3 hours VTI measurement after intravenous administration of 30 mL/kg of crystalloid within 3 hours using ECHO 34 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 21-60 years old both sexes Septic hypotensive patients sedated intubated on controlled mechanical ventilation with no respiratory effort. in need of intravenous fluid administration for resuscitation according to the clinical presentation (systolic arterial blood pressure (BP) < 90 mmHg, or mean arterial pressure (MAP) < 65 mmHg, or a fall of > 20 mmHg from the baseline of MAP, or with signs of hypoperfusion including oliguria less than 0.5 ml/kg/h and arterial lactate > 2.5 mmol/L). Spontaneous breathing poor cardiac echogenicity cardiac arrhythmia Severe valvular heart disease / intracardiac shunt impaired left ventricular function with ejection fraction < 40% ascites pregnancy malignancy congestive heart failure Evidence of fluid over-load renal dysfunction. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 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 06/12/2020 Research ethics committee Faculty of medicine Ain shams University FMASU
Ethics Committee Address
Street address City Postal code Country
Abbassia Cairo 00202 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Changes in COP after fluid therapy using ECHO , Predictive value of EEO and IVC respiratory variation to fluid responsiveness in septic mechanically ventilated patients COP- after fluid therapy
Secondary Outcome Changes in blood pressure in response to fluid therapy Changes in heart rate in response to fluid therapy after fluid therapy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospital ICUs Abbassia Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funding 6th october Giza 00202 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain Shams university Abbassia Cairo 00202 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nevein Fawzy El Sayed Abdelmaksoud Nevein_Fawzy91@yahoo.com 0020201009805569 6th october
City Postal code Country Position/Affiliation
Giza 00202 Egypt Assisstant lecturer of anesthesia Department of Anesthesia Intensive Care and Pain Management FACULTY OF MEDICINE Ain Shams University Cairo Egypt
Role Name Email Phone Street address
Public Enquiries Ahmad Moneer Ahmad Youssef Eldemerdash Ahmedmonier@med.asu.edu.eg 0020201114959206 Abbassia
City Postal code Country Position/Affiliation
Cairo 00202 Egypt lecturer of anesthesia Department of Anesthesia Intensive Care and Pain Management FACULTY OF MEDICINE Ain Shams University Cairo Egypt
Role Name Email Phone Street address
Scientific Enquiries Dalia Fahmy Emam Ali Nawar Daliafahmy78@gmail.com 0020201005183655 Abbasia
City Postal code Country Position/Affiliation
Cairo 00202 Egypt Lecturer of anesthesia Department of Anesthesia Intensive Care and Pain Management FACULTY OF MEDICINE Ain Shams University Cairo Egypt
Role Name Email Phone Street address
Scientific Enquiries Gamal Eldin Mohammad Ahmad Elewa GMELEWA@gmail.com 0020201005195531 Abbasia
City Postal code Country Position/Affiliation
Cairo 00202 Egypt Professor of anesthesia Department of Anesthesia Intensive Care and Pain Management FACULTY OF MEDICINE Ain Shams University Cairo Egypt
Role Name Email Phone Street address
Scientific Enquiries Mayar Hassan Sayed Ahmed El Sersi Mayarelsersi@gmail.com 0020201223929304 Abbasia
City Postal code Country Position/Affiliation
Cairo 00202 Egypt Assistant professor of anesthesia Department of Anesthesia Intensive Care and Pain Management FACULTY OF MEDICINE Ain Shams University Cairo Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data (IPD) will be available Data obtained through this study may be provided to qualified researchers having the same academic interest. the de-identified data that has been requested will be shared as coded with no PHI included. approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party Study Protocol Data requests can be submitted starting 9 months after article publication and the requested data will be made accessible for up to 12 months (extensions will be considered on individual cases basis) access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal as well as statistical analysis and execution of a data sharing agreement.
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