IVC Collapsibility Index or CVP as a Predictor of Fluid Responsiveness in Pediatric Sepsis

May 2, 2025 updated by: Sameh Abdelkhalik Ahmed Ismaiel, Tanta University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Tanta, Egypt, 31511
        • Tanta University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (CVP)
patients in this group will receive fluid resuscitation and therapy guided by central venous pressure.
Procedure: Central venous catheter
Central venous catheter will be introduced to measure central venous pressure
Experimental: Group II (IVC)
patients in this group will receive fluid resuscitation and therapy guided by IVC collapsibility index.
Procedure: Central venous catheter
Central venous catheter will be introduced to measure central venous pressure
Diagnostic test: IVC collapsibility index
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the length of hospital stays
Time Frame: within first 28 days
The number of days from admission of the child till discharge
within first 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The length of PICU stays
Time Frame: within first 28 days
The number of days from admission of child to ICU till discharge from ICU.
within first 28 days
The incidence of complications
Time Frame: within first 28 days
The incidence of acute kidney injury, ARDs, acidosis, severe oedema, or mortality.
within first 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Collaborators

May Rabie Elsheikh
Khalid Mohamed Hassanin Elshemy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2025

Primary Completion (Estimated)

November 14, 2025

Study Completion (Estimated)

November 14, 2025

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR1033/1/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the study had been successfully completed, the data will be shared for other researchers

IPD Sharing Time Frame

6 months from publication of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Clinical Trials on Central venous catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe