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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202409715853957 Date of Registration: 02/09/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Use of the Venous Excess Ultrasound Score as a Bedside Tool to Predict Incidence of Acute Kidney Injury in Patients with Septic Shock
Official scientific title The Use of the Venous Excess Ultrasound Score as a Bedside Tool to Predict Incidence of Acute Kidney Injury in Patients with Septic Shock
Brief summary describing the background and objectives of the trial Sepsis is a major challenge in intensive care unit (ICU) settings.The Surviving Sepsis Campaign international consensus guidelines recommend protocol-driven treatment that uses quantitative resuscitation for emergency department patients with sepsis and septic shock. Fluid administration is a double-edged sword as fluid overload is deleterious in critically ill septic patients; apart from increased mortality, it can cause end-organ failure, thereby increasing the incidence of acute kidney injury (AKI), length of stay in ICU, and duration of mechanical ventilation. There are limited studies focused on assessment of venous congesting due to volume overload after excess IV fluid resuscitation in septic shock and its effect on outcomes. There are no validated tools to objectively identify venous congestion bedside, hence we hypothesize that venous excess ultrasound score (VEXUS)( a 4-step protocol, which uses four parameters, i.e., inferior vena cava, hepatic vein waveform, and portal vein pulsatility, intrarenal venous waveform )correlates with severity of fluid overload and predict AKI incidence. we aim in our study to use vexus score to predict AKI in patients with septic shock.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 25/11/2022
Actual trial start date 01/12/2022
Anticipated date of last follow up 15/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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
Single Group 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 ultrasound radiation 15 minutes Using standard bedside ultrasound of frequency of 3.5 MHz, four areas were determined anatomically then scanned by the ultrasound and a total score was given from 0 to 3. In preparation, the patient was lying supine with the head of the bed lowered to 0º and legs bent to relax the abdominal wall. We positioned on the patient’s right side. A curvilinear probe was used with color Doppler and pulse wave Doppler to perform a successful exam. Step 1: - IVC assessment (B-mode) The diameter of the IVC was commonly measured approximately 1-2 cm caudal to the confluence of the hepatic vein and the IVC. Step 2: Hepatic vein assessment (B-mode, color mode, pulsed wave Doppler mode). Step 3: Portal vein assessment (B-mode, color mode, pulsed wave Doppler mode). Step 4: Renal vein assessment (B-mode, color mode, pulsed wave Doppler mode). Scoring and Validation The VExUS score ranges from Grades 0-3 .In Grade 0, a non-dilated IVC (< 2 cm) indicated that no congestion was present. In Grades 1-3, the IVC diameter is > 2 cm. In Grade 1, a dilated IVC and any combination of normal or mildly abnormal flow patterns (but no severe features) indicated mild congestion. In Grade 2, a dilated IVC and one severely abnormal flow pattern indicated moderate congestion. In Grade 3, a dilated IVC and two or more severely abnormal flow patterns indicated severe congestion. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult patients,age between 18-80years . 2. Patients admitted with septic shock state and admitted to ICU within 24 hour of sepsis diagnosis. 1. Pregnancy 2. Patients discharged from ICU within first 7 days 3. Patients with cardiopulmonary resuscitation 4. Patients with IVC thrombus 5. Patients with conditions that may have interfered with portal Doppler assessment (cirrhosis, portal thrombosis) 6. Patients with chronic kidney disease (estimated glomerular filtration rate < 30mL/min per 1.73 m2 calculated using the Modified Diet in Renal Disease formula or dialysis. 7. Patient with moderate to severe tricuspid regurgitation or impaired EF Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 06/12/2022 menoufia faculty of medicine
Ethics Committee Address
Street address City Postal code Country
yassin abdelghaffar ,shebin elkom menoufia 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Correlation between serial VEXUS score and incidence of AKI in patients with septic shock 7 days from admission and start of intervention
Secondary Outcome Correlation between VEXUS score and fluid balance, clinical signs of fluid overload, right heart function, new onset other organ failure, Length of ICU stay, mechanical ventilation days and in-hospital mortality rates. from admission till discharge of patient
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Hospitals Egypt, Menoufia ,yassin abdelghaffar street menoufia 32951 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
gehad mahmoud fawzi ekhnaton street,elshrouk cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor gehad mahmoud ekhnaton steet cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator gehad mahmoud gehadmahmoud110@gmail.com 0201092539466 ekhnaton street,elshrouk
City Postal code Country Position/Affiliation
cairo Egypt assistant Lecturer of Critical Care Medicine
Role Name Email Phone Street address
Public Enquiries hanady mohammed hanadymhmmd@gmail.com 0201068004428 atef alsadat,shebin elkom
City Postal code Country Position/Affiliation
menoufia Egypt Lecturer of Critical Care Medicine
Role Name Email Phone Street address
Scientific Enquiries ahmed helwa dr.helwaahmed@gmail.com 0201003084212 atef alsadat
City Postal code Country Position/Affiliation
menoufia Egypt Lecturer of Critical Care Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this article ,after deidentification (text, tables, figures, and appendices). Study Protocol immediately following publication , no end date individual participant data that underlie the results reported in this article ,after deidentification (text, tables, figures, and appendices).
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