SepsisNCT06833333
IVC Collapsibility Index or CVP as a Predictor of Fluid Responsiveness in Pediatric Sepsis
A study testing Central venous catheter and IVC collapsibility index in people with Sepsis and Septic Shock, run by Tanta University at 1 site in Egypt.
Trial summary
Pediatric population who suffered from sepsis due to perforated viscus will receive fluid resuscitation guided by either central venous pressure or guided by IVC collapsibility index. The method of guidance of fluid therapy will be applied pre, intra, and postoperatively. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Sepsis, Septic Shock, Perforated Viscus
- What is being tested?
- Central venous catheter and IVC collapsibility index
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2025to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 1 to 5 years presented with septic shock due to perforated viscus according to definition of the American College of Critical Care Medicine and International Pediatric Sepsis Consensus.
Who cannot join
- Refusal of the parents to participate in the study
- Obesity
- Congenital heart diseases
- Severe arrythmias
- Patients developed moderate to severe ARDS
- Massive ascites
- Previous abdominal surgery
- Previous cardiothoracic surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of Inferior Vena Cava Collapsibility Index or Central Venous Pressure as a Predictor of Fluid Responsiveness in Pediatric Sepsis Due to Perforated Viscus: Prospective Randomized Double-blind Study
Pediatric population who suffered from sepsis due to perforated viscus will receive fluid resuscitation guided by either central venous pressure or guided by IVC collapsibility index.
The method of guidance of fluid therapy will be applied pre, intra, and postoperatively.
Primary outcome will be the length of hospital stays, while the secondary outcomes will be the incidence of complications and the length of PICU stays
Read the detailed description
This prospective randomized double-blind study will be carried out on 44 pediatric patients who will be presented to Tanta university hospitals with sepsis owing to perforated viscus, an informed written consent will be obtained from all the parents of the participants, all patients data will be confidential and will be used for the current study only.
Ethical Considerations
Pediatric patients aged 1 to 5 years presented with septic shock due to perforated viscus according to definition of the American College of Critical Care Medicine and International Pediatric Sepsis Consensus will be included
Patients will be randomly classified using a computer-generated software of randomization into 2 groups:
Group I (CVP group): patients in this group will receive fluid resuscitation and therapy guided by central venous pressure.
Group II (IVC group): patients in this group will receive fluid resuscitation and therapy guided by IVC collapsibility.
Patient management Pediatric patients presented with septic shock will be admitted to pediatric intensive care unit (PICU). Intravascular access was established with starting mechanical ventilation and resuscitation. Fluid resuscitation in the form of 10 ml/kg of lactated ringer over 10 minutes will be started if there is one or more of the followings; a) severe tachycardia, b) decrease in systolic blood pressure, c) decrease in urine output less than < 0.5 mL/kg/h, d) prolongation of capillary refill time more than 5 seconds. An ultrasound-guided central venous catheter will be applied. Blood samples will be obtained to measure complete blood count, the renal function, coagulation studies, plasma electrolytes, C- reactive protein, and arterial blood gases. Plain erect X-ray will be done to all patients together with pelvi-abdominal ultrasound.
After initial fluid resuscitation, the fluid therapy volume will be directed according to either central venous pressure or IVC collapsibility index. In group I, the CVP will be measured after initial fluid resuscitation and lactated ringer solution 2 ml/kg over 20 minutes will be given intravenously and can be repeated until reaching CVP of more than 8 mmHg or reaching a total volume of ringer solution to 20 ml/kg. Failure to obtain adequate CVP either maximal dose of fluid (20 ml/kg) or failure to obtain adequate hemodynamics after fluid therapy will be managed by starting vasopressor therapy or inotropic therapy.
In the second group, ultrasound-guided IVC collapsibility index will be done after initial fluid bolus therapy. Lactated ringer solution 2 ml/kg over 20 minutes that can be repeated will be given and repeated until reaching IVC collapsibility index less than 30 % or reaching maximal dose of fluid (20 ml/kg). vasopressor and inotropic therapy will be started if the IVC collapsibility index is not reached despite reaching maximal fluid dose or in failure to obtain stable hemodynamics despite maximal fluid resuscitation.
Once the child is stabilized, he will be admitted to the operating room and received general anesthesia and connected to 5 ASA basal monitors (pulse oximeter, 5-leads ECG, non-invasive blood pressure, End-tidal carbon dioxide, and temperature). The intraoperative fluid and vasopressor therapy will be directed by either CVP or IVC collapsibility index according to the patient group. After completing the surgery, the child will be transported to the PICU on mechanical ventilator with postoperative fluid and vasopressor management according to CVP or IVC collapsibility index according to the patient group. The child general condition, daily laboratory investigations, arterial blood gases, and incidence of complications will be monitored closely.
Measurements:
Primary outcome will be the length of hospital stays, while the secondary outcomes will be the incidence of complications and the length of PICU stays
- Conditions
- Sepsis, Septic Shock, Perforated Viscus, Hospitalism in Children
- Being tested
- Central venous catheter, IVC collapsibility index
- Keywords
- Pediatric, sepsis, Fluid therapy
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central venous catheterProcedure or surgery
Central venous catheter will be introduced to measure central venous pressure
IVC collapsibility indexDiagnostic test
In supine position, IVC will be assessed in the anteroposterior plane in the subxiphoid view using two-dimensional mode till an optimal view of IVC entering the right atrium will be obtained. Then, measurement of its collapsibility will be done.
| Study group | Role | What they receive |
|---|---|---|
| Group I (CVP) | Experimental | patients in this group will receive fluid resuscitation and therapy guided by central venous pressure. Receives: Procedure: Central venous catheter |
| Group II (IVC) | Experimental | patients in this group will receive fluid resuscitation and therapy guided by IVC collapsibility index. Receives: Procedure: Central venous catheter; Diagnostic Test: IVC collapsibility index |
What is being measured
The primary outcome is the main question the study is designed to answer.
the length of hospital stays
The number of days from admission of the child till discharge
Measured: within first 28 days
Secondary outcomes (2)
The length of PICU stays
The number of days from admission of child to ICU till discharge from ICU.
Measured: within first 28 days
The incidence of complications
The incidence of acute kidney injury, ARDs, acidosis, severe oedema, or mortality.
Measured: within first 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start15 Sep 2025 (estimated)
- Primary completion14 Nov 2025 (estimated)
- Study completion14 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833333
- Sponsor's protocol ID
- 36264PR1033/1/25
- Status last verified
- May 2025
- First submitted
- 12 Feb 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the study had been successfully completed, the data will be shared for other researchers
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Inferior Vena Cava Collapsibility Index or Central Venous Pressure as a Predictor of Fluid Responsiveness in Pediatric Sepsis Due to Perforated Viscus: Prospective Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT06833333
- Acronym / sponsor ID
- 36264PR1033/1/25
- Conditions
- Sepsis, Septic Shock, Perforated Viscus, Hospitalism in Children
- Keywords
- Pediatric, sepsis, Fluid therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 14 Nov 2025 (estimated)
- Study completion
- 14 Nov 2025 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pediatric population who suffered from sepsis due to perforated viscus will receive fluid resuscitation guided by either central venous pressure or guided by IVC collapsibility index.
The method of guidance of fluid therapy will be applied pre, intra, and postoperatively.
Primary outcome will be the length of hospital stays, while the secondary outcomes will be the incidence of complications and the length of PICU stays
Detailed description
This prospective randomized double-blind study will be carried out on 44 pediatric patients who will be presented to Tanta university hospitals with sepsis owing to perforated viscus, an informed written consent will be obtained from all the parents of the participants, all patients data will be confidential and will be used for the current study only.
Ethical Considerations
Pediatric patients aged 1 to 5 years presented with septic shock due to perforated viscus according to definition of the American College of Critical Care Medicine and International Pediatric Sepsis Consensus will be included
Patients will be randomly classified using a computer-generated software of randomization into 2 groups:
Group I (CVP group): patients in this group will receive fluid resuscitation and therapy guided by central venous pressure.
Group II (IVC group): patients in this group will receive fluid resuscitation and therapy guided by IVC collapsibility.
Patient management Pediatric patients presented with septic shock will be admitted to pediatric intensive care unit (PICU). Intravascular access was established with starting mechanical ventilation and resuscitation. Fluid resuscitation in the form of 10 ml/kg of lactated ringer over 10 minutes will be started if there is one or more of the followings; a) severe tachycardia, b) decrease in systolic blood pressure, c) decrease in urine output less than < 0.5 mL/kg/h, d) prolongation of capillary refill time more than 5 seconds. An ultrasound-guided central venous catheter will be applied. Blood samples will be obtained to measure complete blood count, the renal function, coagulation studies, plasma electrolytes, C- reactive protein, and arterial blood gases. Plain erect X-ray will be done to all patients together with pelvi-abdominal ultrasound.
After initial fluid resuscitation, the fluid therapy volume will be directed according to either central venous pressure or IVC collapsibility index. In group I, the CVP will be measured after initial fluid resuscitation and lactated ringer solution 2 ml/kg over 20 minutes will be given intravenously and can be repeated until reaching CVP of more than 8 mmHg or reaching a total volume of ringer solution to 20 ml/kg. Failure to obtain adequate CVP either maximal dose of fluid (20 ml/kg) or failure to obtain adequate hemodynamics after fluid therapy will be managed by starting vasopressor therapy or inotropic therapy.
In the second group, ultrasound-guided IVC collapsibility index will be done after initial fluid bolus therapy. Lactated ringer solution 2 ml/kg over 20 minutes that can be repeated will be given and repeated until reaching IVC collapsibility index less than 30 % or reaching maximal dose of fluid (20 ml/kg). vasopressor and inotropic therapy will be started if the IVC collapsibility index is not reached despite reaching maximal fluid dose or in failure to obtain stable hemodynamics despite maximal fluid resuscitation.
Once the child is stabilized, he will be admitted to the operating room and received general anesthesia and connected to 5 ASA basal monitors (pulse oximeter, 5-leads ECG, non-invasive blood pressure, End-tidal carbon dioxide, and temperature). The intraoperative fluid and vasopressor therapy will be directed by either CVP or IVC collapsibility index according to the patient group. After completing the surgery, the child will be transported to the PICU on mechanical ventilator with postoperative fluid and vasopressor management according to CVP or IVC collapsibility index according to the patient group. The child general condition, daily laboratory investigations, arterial blood gases, and incidence of complications will be monitored closely.
Measurements:
Primary outcome will be the length of hospital stays, while the secondary outcomes will be the incidence of complications and the length of PICU stays
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Group I (CVP) | Experimental | Procedure: Central venous catheterpatients in this group will receive fluid resuscitation and therapy guided by central venous pressure. |
| Group II (IVC) | Experimental | Procedure: Central venous catheter, Diagnostic Test: IVC collapsibility indexpatients in this group will receive fluid resuscitation and therapy guided by IVC collapsibility index. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients aged 1 to 5 years presented with septic shock due to perforated viscus according to definition of the American College of Critical Care Medicine and International Pediatric Sepsis Consensus.
Key exclusion criteria (8 listed)
- Refusal of the parents to participate in the study
- Obesity
- Congenital heart diseases
- Severe arrythmias
- Patients developed moderate to severe ARDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central venous catheterCentral venous catheter will be introduced to measure central venous pressure | Procedure or surgery | Group I (CVP), Group II (IVC) |
| IVC collapsibility indexIn supine position, IVC will be assessed in the anteroposterior plane in the subxiphoid view using two-dimensional mode till an optimal view of IVC entering the right atrium will be obtained. Then, measurement of its collapsibility will be done. | Diagnostic test | Group II (IVC) |
Primary outcome
the length of hospital stays
Time frame: within first 28 days
The number of days from admission of the child till discharge
2 secondary outcomes
The length of PICU stays
Time frame: within first 28 days
The incidence of complications
Time frame: within first 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Yes. Once the study had been successfully completed, the data will be shared for other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Central venous catheter and IVC collapsibility index in people with Sepsis and Septic Shock, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sameh Abdelkhalik (01002977048, samehabdelkhalik1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the length of hospital stays (time frame: within first 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.