NCT05096559

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

October 15, 2021

Last Update Submit

October 15, 2021

Conditions

Burn Shock

Outcome Measures

Primary Outcomes (1)

  • • Lactate level

    mmol/L

    24 hours

Secondary Outcomes (1)

  • total vessel density

    24 hours

Interventions

Microcirculation cytocamDEVICE

Visualization of tongue microcirculation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al Ainy hospitals

Cairo, 11562, Egypt

RECRUITING

Central Study Contacts

Shymaa Fathy, MD

CONTACT

+201000455897angel6122003@yahoo.com

Shymaa Mahmoud, MMSc

CONTACT

0106469416dr_shoshomahmoud2003@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and SICU

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 27, 2021

Study Start

February 1, 2021

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

October 27, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)