Non Invasive Evaluation of Fluid Responsiveness in Septic Patient

NCT ID: NCT05310942

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-17
• Study Completion Date: 2023-01-01

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.

Conditions

Septic Shock

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

A

The fluid management of patients in this group will be assessed by IVC collapsibility index (IVC CI) calculated by ultrasound through maximum IVC diameter - minimum IVC diameter divided by maximum diameter then multiplied by 100. If it is less than 50% means that the patient is volume non- depleted while if it is more than 50% means the reverse.

No interventions assigned to this group

B

All patients in this group with sepsis will be evaluated by the electrical cardiometry monitor.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Ebtehal Shaheen

assisstant lecturer at faculty of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine

Banhā, , Egypt

Countries

Egypt

Other Identifiers

MD17-12-2021

Identifier Type: -

Identifier Source: org_study_id