Burn ShockNCT05096559
Evaluation of Sublingual Microcirculation in Burn During Resuscitation
An observational study of Burn Shock, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Shock
- What is being tested?
- Microcirculation cytocam
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with burns greater than 20% TBSA admitted to ICU within the 1st 6 hours post-burn
Who may be able to join
- Age more than 18 years old
- Burn >20% TBSA
- Patients with burn admitted within the 1st 6 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al Ainy hospitals
Cairo, 11562
Shymaa Fathy, 01000455897, angel6122003@yahoo.com
About this study
Official title: 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.
- Conditions
- Burn Shock
- Being tested
- Microcirculation cytocam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcirculation cytocamDevice
Visualization of tongue microcirculation
What is being measured
The primary outcome is the main question the study is designed to answer.
• Lactate level
mmol/L
Measured: 24 hours
Secondary outcomes (1)
total vessel density
mm/mm2
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ShockStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa Fathy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096559
- Sponsor's protocol ID
- N-111-2017
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Sublingual Microcirculation To Guide Fluid Resuscitation In Patients With Burn: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05096559
- Acronym / sponsor ID
- N-111-2017
- Conditions
- Burn Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with burns greater than 20% TBSA admitted to ICU within the 1st 6 hours post-burn
Key inclusion criteria (3 listed)
- Age more than 18 years old
- Burn >20% TBSA
- Patients with burn admitted within the 1st 6 hours
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microcirculation cytocamVisualization of tongue microcirculation | Device | – |
Primary outcome
• Lactate level
Time frame: 24 hours
mmol/L
1 secondary outcome
total vessel density
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Shock, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shymaa Fathy, MD (+201000455897 ext. 002, angel6122003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Lactate level (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.