Non Invasive Evaluation of Fluid Responsiveness in Septic Patient

• Conditions: Septic Shock

• Registration Number: NCT05310942
• Lead Sponsor: Benha University

Brief Summary

The study aims to evaluate the accuracy of fluid responsiveness assessment with non-invasive cardiometry compared to ultrasound guided inferior vena cava (IVC) collapsibility for management of critically ill septic patients with hemodynamic instability.

Detailed Description

Prospective Randomized observational comparative single blinded study will be conducted at intensive care unit at Benha University Hospitals after obtaining approval of the ethical committee and informed written consent from first degree relatives will be issued. The blindness will be performed to the patients.

The study will be conducted according to CONSORT 2010 statement. Enrolment of eligible patients will occur within 8 h of meeting the criteria for septic shock. All patients will be randomized using the computer-generated software of randomization and sealed closed envelopes to allocate them to one of two groups (30 patients each). Routine measurements and investigations will be taken at admission to intensive care unit; history, vital signs, routine laboratory investigation.

Study Timeline

• Study Start: 2021-12-17
• Primary Completion: 2022-01-03
• Status Verified: 2022-03
• Study First Submitted: 2022-03-27
• Study First Submitted QC: 2022-03-27
• Study First Posted: 2022-04-05
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-19
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. ASA class I and II
2. Age 18-65 years old of both genders.
3. Fulfilment criteria of sepsis as defined according to the standard Surviving Sepsis Campaign criteria using the Sequential (sepsis-related) Organ Failure Assessment (SOFA) score (SOFA score ≥ 2 indicated organ dysfunction).
4. Patients within 8 h of meeting the criteria for septic shock.

Exclusion Criteria

1. Lack of consent
2. Age below 18 and above 65 years old.
3. acute coronary syndrome
4. major cardiac dysrhythmia,
5. valvular or congenital heart disease
6. Massive bilateral pleural effusion
7. Severe anaemia
8. End-stage kidney disease (ESKD) patients with Creatinine clearance (CrCl) <50ml/min.
9. Child B and Child C hepatic patients
10. impaired systolic function according to the ejection fraction (EF) (EF < 40% indicated impaired systolic function)
11. Severe ARDS (acute respiratory distress syndrome).
12. Tense ascites
13. Mechanical ventilation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fluid responsiveness	2 years	The study primary outcome will be the cardiac index determined by the non-invasive cardiometry in correlation with ultrasound guided IVC collapsibility index to determine which is more effective in prediction of fluid responsiveness.

Secondary Outcome Measures

Name	Time	Method
total infused fluid from ICU arrival till the goal is achieved	2 years
total dose of vasopressor and inotrope taken during ICU stay period	2 years
time to weaning of vasopressors and inotropes	2 years

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Banhā, Egypt