NCT03805321

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

January 27, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2019

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

January 11, 2019

Last Update Submit

December 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Velocity time integral

    2 hours

  • Mean arterial blood pressure

    2 hours

  • Central venous pressure

    2 hours

  • Systolic arterial blood pressure

    2 hours

  • Diastolic arterial blood pressure

    2 hours

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include septic shock patients undergoing fluid resuscitation. Patients will be enrolled during evaluation of fluid responsiveness.

You may qualify if:

  • Septic shock patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Ahmed Shash, Professor

    Head of department of anesthesia, Cairo University, Egypt

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of anesthesia and critical care

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 15, 2019

Study Start

January 27, 2019

Primary Completion

June 25, 2019

Study Completion

July 1, 2019

Last Updated

December 23, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations