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.: PACTR202602614037605 Date of Registration: 27/02/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Inferior Vena Cava Diameter Guided Fluid Resuscitation versus Conventional Fluid Resuscitation in Patients with Septic Shock
Official scientific title Inferior Vena Cava Diameter Guided Fluid Resuscitation versus Conventional Fluid Resuscitation in Patients with Septic Shock
Brief summary describing the background and objectives of the trial Sepsis is life-threatening organ dysfunction due to dysregulated host response to infection, and septic shock is defined by persisting hypotension requiring vasopressors to maintain a mean arterial pressure of 65 mm Hg or higher and a serum lactate level greater than 2 mmol/L (18 mg/dL) despite adequate volume resuscitation. Septic shock has attracted extensive attention due to its high morbidity and mortality, with current estimates of 30 million episodes and 6 million deaths annually. Fluid resuscitation is one of the most common treatment options for septic shock. According to the surviving sepsis campaign update (SSC) in 2018, fluid resuscitation should be administered within 1 hour after septic shock (HOUR-1 BUNDLE). there is some evidence that conventional strategies (Surviving sepsis campaign-guided fluid treatment) do not improve outcomes. For example, several studies have revealed that early administration of large amounts of crystalloids does not improve prognosis due to complications, and restrictive fluid resuscitation reduces the use of vasoactive drugs and mechanical ventilation. The aim of this study is to assess Inferior Vena Cava (IVC) diameter-guided fluid resuscitation versus Conventional fluid resuscitation in patients with septic shock.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/03/2025
Actual trial start date 10/03/2025
Anticipated date of last follow up 01/03/2026
Actual Last follow-up date 10/03/2026
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants) 68
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 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
Control Group Conventional fluid resuscitation 30 mL/kg loading of normal saline solution Till improvement of the patient - Patients will be treated with 30 mL/kg loading of normal saline solution - After the normal saline solution bolus, treatment with either the additional IV fluid or a vasopressor will be given at the physicians’ discretion during the six-hour study period (as according to MAP – SBP - CVP – UOP – ScVO2 – Lactate clearance). 34 Active-Treatment of Control Group
Experimental Group Inferior Vena Cava Diameter guided fluid resuscitation 10 ml/ kg bolus of normal saline solution without delay Till improvement of the patient - Serial measurements will be immediately performed after each IV bolus was achieved an IVCCI < 40%.  Then, the rate of IV fluid resuscitation will be maintained based on the individual’s condition.  The Inferior Vena Cava (IVC) evaluation will be serially performed and recorded every two hours until six hours after presentation. 34
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult patients (≥18 years old) with septic shock (those with persisting hypotension requiring vasopressors to maintain a mean arterial pressure of 65 mm Hg or higher and a serum lactate level greater than 2 mmol/L (18 mg/dL) despite adequate volume resuscitation) who are diagnosed in the first 6 h. 1) Patients with congestive pulmonary edema or known poor systolic cardiac function (left ventricular ejection fraction ≤ 40%). 2) Patients with known right heart pathology. 3) Patients have or are suspected of having marked ascites, significant bowel dilatation, or conditions that could cause abdominal hypertension. 4) Patients with body mass index ≥ 30 kilograms/meters squared. 5) Patients with concomitant attack of a severe airway disease (eg, asthma or chronic obstructive pulmonary disease that may have confounded the Inferior Vena Cava (IVC) interpretation. 6) Inferior Vena Cava (IVC) could not be identified, or its diameter could not be measured correctly. 7) Patients with end-stage renal disease with or without dialysis. 8) Patients with noninfectious disease as a final diagnosis. 9) Pregnancy. 10) Patients with active hemorrhage. 11) Patients have a living will stating “do not resuscitate”. 12) Patients declined to consent. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 94 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 01/02/2025 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Yassen Abd Al Ghafar Shebin ElKom 23511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The 30-day mortality outcome of patients with sepsis-induced tissue hypoperfusion (SITH) and septic shock (SS) who will be treated with Inferior Vena Cava diameter guided fluid management compared with those treated with the conventional strategy. 12 Months from beginning of the study
Secondary Outcome - The six-hour lactate clearance, amount of intravenous (IV) fluid, rate of vasopressor and mechanical ventilator (MV) use. - Change in sequential organ failure assessment (SOFA) score at 72 hours. - Change in Acute Physiology and Chronic Health Evaluation (APACHEII) score. -- Length of stay in ICU. 12 Months from beginning of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Hospital and Shebin El Kom Teaching Hospital Shebin El Kom Menoufia 23511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Adel Mohamed Abd El Aziz Yassen Abd al Ghafar Shebin El Kom 23511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menoufia University Hospital Shebin El Kom Menoufia 23511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Mohamed Abd El Aziz Icudoctoradel@gmail.com +201007351105 Yassen Abd Al Ghafar
City Postal code Country Position/Affiliation
Shebin El Kom 23511 Egypt Faculty of Medicine. Menoufia University
Role Name Email Phone Street address
Public Enquiries Wessam Eldin Abd El Rahman Sultan wesamsultan@med.menofia.edu.eg +201010122125 Yassen Abd Al Ghafar
City Postal code Country Position/Affiliation
Shebin El Kom 23511 Egypt Faculty of Medicine. Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Amany Said Abd El Haleem Amany.saeed.12@med.menofia.edu.eg +201009404539 Yassen Abd Al Ghafar
City Postal code Country Position/Affiliation
Shebin El Kom 23511 Egypt Faculty of Medicine. Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Mohammed Fathi Abd El Aziz Dr_mohamed_fathy251@yahoo.com +201002209632 Yassen Abd Al Ghafar
City Postal code Country Position/Affiliation
Shebin El Kom 23511 Egypt Faculty of Medicine. Menoufia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No Individual Participant Data sharing according to request of the patients Statistical Analysis Plan,Study Protocol None This prospective randomized controlled trial (RCT) will be conducted on 68 adult (≥18 years old) non-traumatic sepsis-induced tissue hypoperfusion and septic shock patients who presented to the Emergency Department (ED) during the study period. Patient eligibility will be assessed by emergency physicians during all work shifts. We will include patients who will be admitted to the Intensive Care Unit Department at Menoufia University Hospitals after approval of the local Ethics Committee. A written informed consent will be obtained from patient's legal surrogates.
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 27/02/2026 PACTR Admin Adult: 19 Year-44 Year, 80 and over: 80+ Year Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year