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

NCT05289388 | Unknown

• 1 other identifier: N182022
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• the ability of Lactate/CRT index in predicting patient's outcome

  multiplying the CRT and serum lactate

  6 hour after admission

Secondary Outcomes (5)

• ability of Lactate/CRT index in predicting patient's outcome

  12 hours after admission

• ability of Lactate in predicting patient's outcome

  6 and 12 hours after admission

• ability of CRT in predicting patient's outcome

  6 and 12 hours after admission

• change in serum lactate

  WITHIN 1 HOUR, 6 and 12 hours after admission

• change in CRT

  WITHIN 1 HOUR, 6 and 12 hours after admission

Interventions

Lactate/CRT index DIAGNOSTIC_TEST

index will be calculated as the product of multiplying the CRT and serum lactate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)"

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• ahmed hasanin

  Cairo University Kasr Alainy Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maha Mostafa

CONTACT

01000365115; maha.mostafa@cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: March 21, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)