Evaluation of Sublingual Microcirculation in Burn During Resuscitation

Burn Shock Clinical Trial

Official title:

The Evaluation of Sublingual Microcirculation To Guide Fluid Resuscitation In Patients With Burn: Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05096559
• Other study ID #: N-111-2017
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: October 2021
• Source: Cairo University
• Contact: Shymaa Fathy, MD
• Phone: +201000455897
• Email: angel6122003[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The adequacy of fluid resuscitation will be monitored in burn patients using microcirculation. Microcirculation camera will be placed on the base of the tongue and at different four quadrants. • Microcirculation parameters at baseline and after 8h , 16h and 24h of fluid resuscitation will be recorded. Fluid resuscitation with lactated ringer according to Parkland formula (4 ml/kg/%TBSA) 50% given during the first 8 hours, with the remainder given during the following 16 hours, will be initiated to maintain a urinary output of 0.5ml/kg/hr.Norepinephrine infusion will be started in case of circulatory failure at a rate of 0.02mic/kg/min to maintain MAP of 65-70mmHg.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age more than 18 years old
• Burn >20% TBSA
• Patients with burn admitted within the 1st 6 hours

Exclusion Criteria:

• Age < 18 years old.
• Pregnant patients.
• Patients with severe renal insufficiency.
• Patients shocked due to other causes as sepsis, hypovolaemia or cardiogenic shock
• Patients with airway edema that preclude the measurement of sublingual microcirculation

Related Conditions & MeSH terms

• Burn Shock
• Burns

Intervention

Device:
• Microcirculation cytocam
Visualization of tongue microcirculation

Locations

Country	Name	City	State
Egypt	Kasr Al Ainy hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Lactate level	mmol/L	24 hours
Secondary	total vessel density	mm/mm2	24 hours