Clinical trial NCT03805321: The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness
Official title: The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness Using Mini-fluid Challenge Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include septic shock patients undergoing fluid resuscitation. Patients will be enrolled during evaluation of fluid responsiveness.

Brief 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 .

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Septic shock patients

Exclusion Criteria:

* Evident blood loss
* Peripheral vascular disorders
* Upper limb injury or burns

Primary outcomes:
measure: Peripheral perfusion index
timeFrame: 2 hours
Secondary outcomes:
measure: Velocity time integral
timeFrame: 2 hours
measure: Mean arterial blood pressure
timeFrame: 2 hours
measure: Central venous pressure
timeFrame: 2 hours
measure: Systolic arterial blood pressure
timeFrame: 2 hours
measure: Diastolic arterial blood pressure
timeFrame: 2 hours
measure: Cardiac output
timeFrame: 2 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mohamed Hasanin
Study officials:
affiliation: Head of department of anesthesia, Cairo University, Egypt
name: Ahmed Shash, Professor
role: STUDY_DIRECTOR
References:
citation: Hasanin A, Karam N, Mukhtar AM, Habib SF. The ability of pulse oximetry-derived peripheral perfusion index to detect fluid responsiveness in patients with septic shock. J Anesth. 2021 Apr;35(2):254-261. doi: 10.1007/s00540-021-02908-w. Epub 2021 Feb 22.