Non Invasive Evaluation of Fluid Responsiveness in Septic Patient

Septic Shock Clinical Trial

Official title:

Comparing the Non Invasive Cardiometry With Ultrasound Guided Inferior Vena Cava Collapsibility for Evaluation of Fluid Responsiveness in Septic Patient; Randomized Clinical Trials

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05310942
• Other study ID #: MD17-12-2021
• Status: Active, not recruiting
• Start date: December 17, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 1, 2023
• Est. primary completion date: January 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid responsiveness	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.	2 years
Secondary	total infused fluid from ICU arrival till the goal is achieved		2 years
Secondary	total dose of vasopressor and inotrope taken during ICU stay period		2 years
Secondary	time to weaning of vasopressors and inotropes		2 years