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.: PACTR202402670134278 Date of Approval: 29/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Superior vena Cava Collapsibility Index versus Pulse Pressure Variability Index for Fluid Management in Major Abdominal Surgeries, a Non-inferiority Study
Official scientific title Superior vena Cava Collapsibility Index versus Pulse Pressure Variability Index for Fluid Management in Major Abdominal Surgeries, a Non-inferiority Study
Brief summary describing the background and objectives of the trial Optimization of tissue perfusion and oxygen delivery to the body organs, while avoiding hyper and hypovolemia, remain the cornerstone of hemodynamic care. Debate about the optimum strategy for fluid intervention for abdominal surgery included the type of fluid used and the targeted replacement volume. Major abdominal surgery is a complex procedure with a high incidence of perioperative complications. Restrictive fluid management strategy was not associated with a higher rate of disability-free survival and even was associated with a higher rate of acute kidney injury. 1–3 The importance of the prediction of fluid responsiveness relies on the fact that the fluid loading in such condition may be hazardous for the patient, by causing tissue edema and increasing pulmonary water content. The expected response to fluid infusion is an increase of the cardiac output (CO) or stroke volume (SV), and this response depends mostly on the position of an individual patient on the cardiac function curve, i.e., the Frank-Starling curve4–6. Many indices have been proposed to predict FR, the so-called dynamic indices (pulse pressure variation (PPV), stroke volume variation (SVV), and systolic pressure variation (SPV). However, these studies mainly concern ICU settings, septic, or postoperative patients7–9. Among dynamic fluid indices, the pulse pressure variation is considered to be the most accurate and frequently serves as a gold standard in the evaluation of new dynamic variables.10 Most of dynamic fluid indices has either limitations or technical difficulties that is maximized in open abdominal surgeries. Using transesophageal echocardiography for SV variability or ventricular measurements is technically difficult and is an existing option in many centers. Obviously, inferior vena cava (IVC) collapsibility; one the commonly used indicator of fluid status, is not applicable in open abdominal surgeries. Superior vena caval diameter collapsibility index (SVCCI) has been proposed as a non-invasive alternative because of the easiness of the technique and possibility of application in open abdominal surgeries. Intraoperative trans-thoracic doppler over the SVC over the left parasternal area has been described and can be applied without interrupting surgery. In this study, we will compare the intraoperative measurement of using SVC collapsibility index versus PPV as adynamic index for fluid administration during open abdominal surgeries. Fluid management will be primarily guided by PPV index starting fluid boluses at 13% variability. At the same time, SVCI will be measured and compared to PPV to calculate the sensitivity and specificity, and diagnostic accuracy of SVCI as a fluid index.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 16/03/2024
Actual trial start date 16/03/2024
Anticipated date of last follow up 15/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status 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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Superior Vena Cava collapsibility index Hemodynamic parameters (including PPV, SVCCI, predicted FR) will be recorded routinely every 30 min during the surgery and with each hypotensive episode (MAP less than 60 mmHg or a decrease with more than 20% of the basal reading). Hemodynamic parameters (including PPV, SVCCI, predicted FR) will be recorded routinely every 30 min during the surgery and with each hypotensive episode (MAP less than 60 mmHg or a decrease with more than 20% of the basal reading). The probe position and measurement of SVC by TTE. The parasternal long-axis view was obtained at the left parasternal between the third and fourth intercostal spaces with the probe marker pointing toward the patient’s right shoulder. The SVC diameter over a single respiratory cycle (SVCmax1, SVCmin1) will be measured, and SVCCI will be calculated as SVCCI = (SVCmax-SVCmin) /SVCmax. 80
Control Group Pulse pressure variability group Hemodynamic parameters (including PPV, SVCCI, predicted FR) will be recorded routinely every 30 min during the surgery and with each hypotensive episode (MAP less than 60 mmHg or a decrease with more than 20% of the basal reading). Hemodynamic parameters (including PPV, SVCCI, predicted FR) will be recorded routinely every 30 min during the surgery and with each hypotensive episode (MAP less than 60 mmHg or a decrease with more than 20% of the basal reading). Depending on the arterial waveform, the PPV will b calculated as the following PPV= (PPmax - PPmin)/PPmean. Mean pulse pressure equals (PPmax+PPmean)/2. The data will be automatically collected form the monitoring system. 80 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The recruited patients will include those scheduled for major abdominal surgery (defined as an intraperitoneal operation with no primary involvement of the thorax, involving either luminal resection and/or resection of a solid organ associated with the gastrointestinal tract11), Age range from 18- to 60 years, American Society of Anesthesiologists (ASA) class I-II. surgeries extending to the thorax, emergency surgeries, transplant surgeries, preoperative renal dysfunction, BMI >40, and preoperative coagulopathy, previous thoracotomy, known congenital heart disease. 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
No 26/02/2024 Instututional research board Mansoura University
Ethics Committee Address
Street address City Postal code Country
Elgomhoreya Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Diagnostic accuracy SVC diameter collapsibility Hemodynamic parameters SVCCI will be recorded routinely every 30 min during the surgery and with each hypotensive episode during surgery
Secondary Outcome Sensitivity of SVC collapsibility index test Hemodynamic parameters SVCCI will be recorded routinely every 30 min during the surgery and with each hypotensive episode
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospitals Elgomhoreya street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
MAnsoura University Elgomhoreya MAnsoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alrefaey Kandeel Elgomhoreya Masnoura 35516 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarek Ramadan dr_tarekhabeeb@yahoo.com 00201005663554 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura University
Role Name Email Phone Street address
Public Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com 00201064203475 Geihan
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com 00201064203475 Geihan
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes depersonalized IPD data, study plan, methods, statistical plan and result tables will be shared upon requests fulfilling the access criteria mentioned below Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 6 months and up to 2 years after study publication depersonalized IPD data sets supporting the study results will be available for researchers or organizations supported by related ethical committee or similar. Data can be requested through contacting email (refa3ey2@yahoo.com) and the request approval will be decided by institutional research board -Mansoura university when needed.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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