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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05289388
• Other study ID #: N182022
• Status: Not yet recruiting
• Start date: March 2022
• Est. completion date: June 2022

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: Maha Mostafa
• Phone: 01000365115
• Email: maha.mostafa[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Diagnostic Test:
• Lactate/CRT index
index will be calculated as the product of multiplying the CRT and serum lactate

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the ability of Lactate/CRT index in predicting patient's outcome	multiplying the CRT and serum lactate	6 hour after admission
Secondary	ability of Lactate/CRT index in predicting patient's outcome	multiplying the CRT and serum lactate	12 hours after admission
Secondary	ability of Lactate in predicting patient's outcome	mg/dl	6 and 12 hours after admission
Secondary	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
Secondary	change in serum lactate	the difference between each two-consecutive measurement	WITHIN 1 HOUR, 6 and 12 hours after admission
Secondary	change in CRT	the difference between each two-consecutive measurement	WITHIN 1 HOUR, 6 and 12 hours after admission