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NCT Number: NCT03805321

The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness

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 .

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Septic shock patients

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 15, 2019
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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