Evaluation of Sublingual Microcirculation in Burn During Resuscitation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Burn Shock
• Intervention / Treatment: Device: Microcirculation cytocam

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Shymaa Fathy, MD; Phone Number: 002 +201000455897; Email: angel6122003@yahoo.com
• Study Contact Backup: Name: Shymaa Mahmoud, MMSc; Phone Number: 002 0106469416; Email: dr_shoshomahmoud2003@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • Kasr Al Ainy Hospitals
    • Contact: Shymaa Fathy; Phone Number: 01000455897; Email: angel6122003@yahoo.com

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

Patients with burns greater than 20% TBSA admitted to ICU within the 1st 6 hours post-burn

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Lactate level	mmol/L	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total vessel density	mm/mm2	24 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: N-111-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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