The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness

Septic Shock Clinical Trial

Official title:

The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness Using Mini-fluid Challenge Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805321
• Other study ID #: N-138-2018
• Status: Completed
• Start date: January 27, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: December 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fluid therapy is an essential component of the management of patients with acute circulatory failure. Nevertheless, unnecessary administration of fluids in non-responders is harmful. Thus, the concept of fluid responsiveness has been suggested to guide fluid administration in critically ill patients to avoid either over or under-transfusion. The aim of this work is to investigate the ability of peripheral perfusion index to predict the hemodynamic response to mini-fluid challenge in patients with septic shock .

Description:

The concept of fluid responsiveness has been suggested to guide fluid administration in critically ill patients to avoid either over or under-transfusion.

Several methods have been suggested to detect fluid responsiveness. Mini fluid challenge with concomitant monitoring of stroke volume is one of the most robust methods for pre-load challenge.

The main foreshortening of mini fluid challenge method is the need for a real-time cardiac output monitor, to track the instantaneous change of stroke vole with changing body position. Finding a surrogate to cardiac output to trace the effect of mini fluid challenge would make the test more applicable without the need for advanced hemodynamic monitors.

There is a growing interest in the use of perfusion indices in assessment of fluid responsiveness. Perfusion indices are measures for adequacy of oxygen delivery in peripheral tissues; thus, they were hypothesized to be possible surrogates of cardiac output. Peripheral perfusion index represents "the ratio between the pulsatile and non-pulsatile component of the light reaching the pulse oximeter" . Peripheral perfusion index has been considered as a numerical non-invasive measure for peripheral perfusion. PPI has the advantage over other perfusion indices that it a non-invasive, user-friendly monitor.

The aim of this work is to investigate the ability of peripheral perfusion index to predict the hemodynamic response to mini-fluid challenge in patients with septic shock.

Mini-fluid challenge test will be performed by infusion of 200 mL Lactated Ringer's solution over 1 minute. Velocity time integral will be monitored using Transthoracic echocardiography at the left ventricular outflow tract at the apical five-chamber view. Cardiac output will be calculated, and the patient will be considered fluid-responder if cardiac output increased by 10% after fluid challenge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 1, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Septic shock patients

Exclusion Criteria:

• Evident blood loss

• Peripheral vascular disorders

• Upper limb injury or burns

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Locations

Country	Name	City	State
Egypt	Ahmed Mohamed Hasanin	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral perfusion index	It is a number describing the ratio between pulsatile and non-pulsatile blood flow measured by pulse oximeter. It is measured in percent. with the best value of 20% and the worst value of 0.1%	2 hours
Secondary	Velocity time integral	it is a parameter measured from Doppler across the left ventricular outflow tract. It is calculated by dividing the blood velocity by time and measured in cm	2 hours
Secondary	Mean arterial blood pressure	Mean arterial blood pressure measured in mmHg	2 hours
Secondary	Central venous pressure	Central venous pressure measured from a central venous catheter. It is measured in cmH2o	2 hours
Secondary	Systolic arterial blood pressure	Systolic arterial blood pressure measured in mmHg	2 hours
Secondary	Diastolic arterial blood pressure	Diastolic arterial blood pressure measured in mmHg	2 hours
Secondary	Cardiac output	The amount of blood pumped by the heart in one minute. it is measured as liters per minute	2 hours