The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness

• ClinicalTrials.gov Identifier: NCT03805321
• Recruitment Status: Completed
• First Posted: January 15, 2019
• Last Update Posted: December 23, 2020
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ahmed Hasanin, Cairo University

Study Description

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 .

Condition or disease
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.

Study Design

• Study Type: Observational
• Actual Enrollment: 57 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness Using Mini-fluid Challenge Test
• Actual Study Start Date: January 27, 2019
• Actual Primary Completion Date: June 25, 2019
• Actual Study Completion Date: July 1, 2019

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Peripheral perfusion index [ Time Frame: 2 hours ]
   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%

Secondary Outcome Measures :

1. Velocity time integral [ Time Frame: 2 hours ]
   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. Mean arterial blood pressure [ Time Frame: 2 hours ]
   Mean arterial blood pressure measured in mmHg
3. Central venous pressure [ Time Frame: 2 hours ]
   Central venous pressure measured from a central venous catheter. It is measured in cmH2o
4. Systolic arterial blood pressure [ Time Frame: 2 hours ]
   Systolic arterial blood pressure measured in mmHg
5. Diastolic arterial blood pressure [ Time Frame: 2 hours ]
   Diastolic arterial blood pressure measured in mmHg
6. Cardiac output [ Time Frame: 2 hours ]
   The amount of blood pumped by the heart in one minute. it is measured as liters per minute

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

Inclusion Criteria:

• Septic shock patients

Exclusion Criteria:

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

Contacts and Locations

Locations

Egypt

Ahmed Mohamed Hasanin

Cairo, Egypt, 11432

Sponsors and Collaborators

Cairo University

Investigators

• Study Director: Ahmed Shash, Professor; Head of department of anesthesia, Cairo University, Egypt

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ahmed Hasanin, Assistant professor of anesthesia and critical care, Cairo University
• ClinicalTrials.gov Identifier: NCT03805321
• Other Study ID Numbers: N-138-2018
• First Posted: January 15, 2019
• Last Update Posted: December 23, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Shock, Septic; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Shock