Non Invasive Evaluation of Fluid Responsiveness in Septic Patient

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05310942

Enrollment

Registered

2022-04-05

Start date

2021-12-17

Completion date

2023-01-01

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

fluid responsiveness, cardiometry, IVC collapsibility

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

Egypt

Outcome results