a Novel Index for Tissue Perfusion in Predicting Outcome in Patients With Septic Shock

The Reliability of a Novel Index for Tissue Perfusion in Predicting Outcome in Patients With Septic Shock: a Prospective Observational Study.

Septic shock is a life-threatening condition with mortality rate of up to -40%. Septic shock is catheterized by altered microcirculation that leads to tissue hypoperfusion and ultimately multi-organ dysfunction. Hence, maintenance of adequate tissue perfusion is the mainstay of resuscitation of patients with septic shock.

Serum lactate is still considered the gold standard for evaluation of tissue perfusion. Thus, according to the latest definition, elevated serum lactate, as an indicator of tissue hypo-perfusion, is required for diagnosis of septic shock. However, lactate level change in response to resuscitation is slow even in survivors.

Capillary refill time (CRT) is a simple method for assessing peripheral perfusion. Monitoring CRT was found to be a good tool for guiding resuscitation and delayed CRT showed good ability in predicting mortality in patients with septic shock.

To the best of our knowledge, there is no previous report assessing the reliability of an index that include both serum lactate and CRT (lactate/CRT index) in predicting mortality in patients with septic shock.

We hypothesize that the lactate/CRT index would have good accuracy in predicting mortality in patient with septic shock.

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Diagnostic test: Lactate/CRT index

Detailed Description

All patients will be monitored with; non-invasive and invasive arterial blood pressure, five-lead electrocardiography (ECG), hourly urinary output, and central venous pressure (CVP). Management of the patients will be done according to the latest surviving sepsis campaign guidelines in 2016. APACHE II score will be calculated on the time of admission using MDCalc ©.

Arterial blood gases, including serum lactate (blood gas analysis device GEM premier 300, Instrumentation Laboratory, Bedford, MA, USA), will be obtained at the time of intensive care unit admission, 6 and 12 hours after admission. Capillary refill time will be measured by applying enough pressure to cause skin blanching to the ventral surface of the distal phalanx of right index finger and the pressure will be then maintained for 10 seconds. The time for return of the normal skin color will be registered with a stopwatch. CRT will be recoded at the same time point as the blood sample.

The change in serum lactate (∆ Lactate), and CRT (∆ CRT) will be calculated as the difference between each two-consecutive measurement. Lactate/CRT index will be calculated as the product of multiplying the CRT and serum lactate.

• Study Type: Observational
• Enrollment (Anticipated): 34

Contacts and Locations

• Study Contact: Name: Maha Mostafa; Phone Number: 01000365115; Email: maha.mostafa@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All consecutive patients with clinically suspected septic shock according to the latest definition of septic shock (sepsis-3) "hypotension in a patient with sepsis requiring vasopressor therapy to maintain mean arterial pressure above 65 mmHg despite adequate fluid resuscitation in addition to elevated serum lactate level (above 2 mmol/L)"

Description

Inclusion Criteria:

• Patients with clinically suspected septic shock, older than 18 years old

Exclusion Criteria:

• Patients less than 18 years.
• patients with evident blood loss.
• patients with metastatic cancer.
• Patients with Child B or C liver cirrhosis
• patients with estimated glomerulo filtartion rate less than 30 ml/min/m2

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the ability of Lactate/CRT index in predicting patient's outcome	multiplying the CRT and serum lactate	6 hour after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ability of Lactate/CRT index in predicting patient's outcome	multiplying the CRT and serum lactate	12 hours after admission
ability of Lactate in predicting patient's outcome	mg/dl	6 and 12 hours after admission
ability of CRT in predicting patient's outcome	Capillary refill time will be measured by applying enough pressure to cause skin blanching to the ventral surface of the distal phalanx of right index finger and the pressure will be then maintained for 10 seconds. The time for return of the normal skin color will be registered with a stopwatch	6 and 12 hours after admission
change in serum lactate	the difference between each two-consecutive measurement	WITHIN 1 HOUR, 6 and 12 hours after admission
change in CRT	the difference between each two-consecutive measurement	WITHIN 1 HOUR, 6 and 12 hours after admission

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: March 13, 2022
• First Submitted That Met QC Criteria: March 13, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: N182022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the protocol and data supporting this study will be available from the PI upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No