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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05096559
Other study ID # N-111-2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT05612867 - Low Dose Vitamin C in Burns >20% Compared to Previous Studies With High Dose Vitamin C