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

NCT ID: NCT06833333

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2025-11-14

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group I (CVP)

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

Group Type: EXPERIMENTAL

Central venous catheter

Intervention Type: PROCEDURE

Central venous catheter will be introduced to measure central venous pressure

Group II (IVC)

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

Group Type: EXPERIMENTAL

Central venous catheter

Intervention Type: PROCEDURE

Central venous catheter will be introduced to measure central venous pressure

IVC collapsibility index

Intervention Type: 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.

Interventions

Central venous catheter

Central venous catheter will be introduced to measure central venous pressure

Intervention Type: PROCEDURE

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sameh Abdelkhalik Ahmed Ismaiel

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University hospitals

Tanta, , Egypt

Countries

Egypt

Central Contacts

Sameh Abdelkhalik

Role: CONTACT

samehabdelkhalik1982@gmail.com

01002977048

Other Identifiers

36264PR1033/1/25

Identifier Type: -

Identifier Source: org_study_id