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

NCT06833333 | Not Yet Recruiting

• 1 other identifier: 36264PR1033/1/25
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Pediatric; sepsis; Fluid therapy

Outcome Measures

Primary Outcomes (1)

• the length of hospital stays

  The number of days from admission of the child till discharge

  within first 28 days

Secondary Outcomes (2)

• The length of PICU stays

  within first 28 days

• The incidence of complications

  within first 28 days

Study Arms (2)

Group I (CVP)

EXPERIMENTAL

patients in this group will receive fluid resuscitation and therapy guided by central venous pressure.

Procedure: Central venous catheter

Group II (IVC)

EXPERIMENTAL

patients in this group will receive fluid resuscitation and therapy guided by IVC collapsibility index.

Procedure: Central venous catheter; Diagnostic Test: IVC collapsibility index

Interventions

Central venous catheter PROCEDURE

Central venous catheter will be introduced to measure central venous pressure

Group I (CVP); Group II (IVC)

IVC collapsibility index DIAGNOSTIC_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.

Group II (IVC)

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University hospitals

Tanta, 31511, Egypt

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Central Venous Catheters

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Vascular Access Devices; Catheters; Equipment and Supplies

Central Study Contacts

Sameh Abdelkhalik

CONTACT

01002977048; samehabdelkhalik1982@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The investigated patients are children aged 1-5 years. Measurements will be obtained by an assistant nurse not participating in the study and blinded to its groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: September 15, 2025
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 6 months from publication of the study

Locations

EG (1)