Non Invasive Evaluation of Fluid Responsiveness in Septic Patient

NCT05310942 | Unknown

• 1 other identifier: MD17-12-2021
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

fluid responsiveness; cardiometry; IVC collapsibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

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.

B

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• ASA class I and II
• Age 18-65 years old of both genders.
• 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).
• Patients within 8 h of meeting the criteria for septic shock.

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Faculty of Medicine

Banhā, 13518, Egypt

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer at faculty of medicine

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 5, 2022
• Study Start: December 17, 2021
• Primary Completion: January 3, 2022
• Study Completion: January 1, 2023
• Last Updated: April 19, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)