BurnsPhase 1/2NCT06126991
Organ Protective Effect of Cetirizine In Patients With Severe Burns
A Phase 1/2 study testing Cetirizine and Midazolam and Fentanyl in people with Burns, run by Ruijin Hospital at 1 site in China.
Trial summary
This prospective clinical trial aims to investigate the organ protective effects of cetirizine in patients with severe burns. Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Burns
- What is being tested?
- Cetirizine and Midazolam and Fentanyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2024to 31 Dec 2025
- Phase
- Phase 1/2
- 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 12 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed and dated informed consent form
- Commitment to comply with the procedures and cooperation during the course
- TBSA >30% and admitted within the first day after burns
- No severe compound injuries
Who cannot join
- History of allergy to drugs in the trial
- Postoperative complications that would interfere with the observation
- Mental illness and severe heart disease, hypertension
- Serious genetic diseases
- Incomplete clinical information (unclear diagnosis, incomplete medical history, incomplete medication records, etc.)
- Pregnancy/lactation
Show all 10Show fewer
- Malignant tumors
- Organ insufficiency due to previous chronic diseases such as hypertension, diabetes mellitus or non-burning factors
- Serious adverse reactions
- Self-requested withdrawal
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Burn, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Yan Liu, 021-64370045, rjliuyan@126.com
About this study
Official title: Organ Protective Effect of Histamine H1 Receptor Antagonist In Patients With Severe Burns: A Clinical Study
This prospective clinical trial aims to investigate the organ protective effects of cetirizine in patients with severe burns.
Read the detailed description
This is a prospective, randomized, single-blind, parallel-controlled clinical trial. The global objective is to compare the organ protective effects of the sedation and analgesia regimen (midazolam, fentanyl) with the modified sedation and analgesia regimen (midazolam, fentanyl, cetirizine) in patients with severe burns (≥30% TBSA). Participants will receive the intervention from admission to 72 hours post-burn. Researchers will take the APACHE II scores on days 7 after admission as the main outcomes. Researchers will also take other supplementary examination results into account, including liver enzyme, myocardial enzyme, renal function, haemodynamic index, coagulation function, and pulmonary interstitial edema.
- Conditions
- Burns
- Being tested
- Cetirizine, Midazolam and Fentanyl
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetirizineDrug
Oral administration of cetirizine at 10mg once daily will be used.
Midazolam and FentanylDrug
Midazolam 50mg + fentanyl 300ug micro pump push will be used with a starting dose of 5ml/hour, adjusted according to the patient's level of sedation. The patient's RASS score will be maintained between -1-0 and the drug will be suspended with a blood pressure below 90/60mmHg.
| Study group | Role | What they receive |
|---|---|---|
| The Modified Sedation and Analgesia Regimen Group | Experimental | midazolam, fentanyl, cetirizine Receives: Drug: Cetirizine; Drug: Midazolam and Fentanyl |
| The Sedation and Analgesia Regimen Group | Active comparator | midazolam, fentanyl Receives: Drug: Midazolam and Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
APACHE II on Day 7
Observation of APACHE II scores of patients in each group 7 days after admission.
The APACHE II (Acute Physiology And Chronic Health Evaluation II) is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements. Higher scores correspond to more severe disease and a higher risk of death.
Measured: Day 7
Secondary outcomes (20)
Urinary Output
Observation of 24-hour urinary output (ml) 7 days after admission.
Measured: Day 7
Blood L-lactate
Observation of Blood L-lactate level 7 days after admission.
Measured: Day 7
Base Excess (BE)
Observation of base excess in blood 7 days after admission.
Measured: Day 7
Oxygen Saturation
Observation of oxygen saturation in blood 7 days after admission.
Measured: Day 7
Stroke Volume Variation
Observation of stroke volume variation (SVV) in PICCO or Uscom 7 days after admission.
Measured: Day 7
Global End-Diastolic Volume
Observation of global end-diastolic volume (GEDV) in PICCO or Uscom 7 days after admission.
Measured: Day 7
Central Venous Pressure
Observation of central venous pressure (CVP) in PICCO or Uscom 7 days after admission.
Measured: Day 7
Stroke Volume
Observation of stroke volume 7 days after admission.
Measured: Day 7
Cardiac Function Index
Observation of Cardiac Function Index (CFI) 7 days after admission.
Measured: Day 7
Pulmonary interstitial edema
Observation of extravascular lung water index (ELWI) or chest x-ray 7 days after admission.
Measured: Day 7
SOFA Score
Observation of SOFA score 7 days after admission.
The SOFA score (Sequential Organ Failure Assessment Score) is a scoring system associated with the organ function or rate of function of patients. An integer score from 0 to 24 is computed based on 6 different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Higher scores correspond to more severe organ function disorders or failures.
Measured: Day 7
Body Temperature
Observation of body temperature 7 days after admission.
Measured: Day 7
Heart Rate
Observation of heart rate 7 days after admission.
Measured: Day 7
Respiratory Rate
Observation of respiratory rate 7 days after admission.
Measured: Day 7
Leukocyte Count
Observation of leukocyte count in blood 7 days after admission.
Measured: Day 7
Blood CRP
Observation of blood CRP (C-reactive protein) 7 days after admission.
Measured: Day 7
Blood Calcitoninogen
Observation of blood calcitoninogen 7 days after admission.
Measured: Day 7
Mechanical Ventilation Duration
Observation of mechanical ventilation duration during 28 days after admission.
Measured: Day 28
Mortality
Observation of mortality during 28 days after admission.
Measured: Day 28
Sepsis Rate
Observation of sepsis rate during 28 days after admission.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start23 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Liu, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126991
- Sponsor's protocol ID
- RuijinH_20230318
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang M, Yang P, Yu T, Harmsen MC, Gao M, Liu D, Shi Y, Liu Y, Zhang X. Lytic cocktail: An effective method to alleviate severe burn induced hyper-metabolism through regulating white adipose tissue browning. Heliyon. 2022 Mar 17;8(3):e09128. doi: 10.1016/j.heliyon.2022.e09128. eCollection 2022 Mar.
PubMed 35846468Wang J, Lu C, Zhang J, Gao M, Liu D, Yang P, Yu T, Wang X, Zhang X, Liu Y. LYTIC COCKTAIL ATTENUATES CATECHOLAMINE SURGE AFTER SEVERE BURNS BY BLOCKING HISTAMINE H1 RECEPTOR/PKA/CREB/TYROSINE HYDROXYLASE SIGNALING IN CHROMAFFIN CELLS. Shock. 2022 Aug 1;58(2):158-168. doi: 10.1097/SHK.0000000000001963. Epub 2022 Jul 24.
PubMed 35953455Wang J, Lu C, Liu X, Zhang G, Zhang J, Gao M, Liu D, Zhang X, Liu Y. Histamine H1 receptor antagonist attenuates catecholamine surge and organ injury after severe burns. Front Endocrinol (Lausanne). 2023 Feb 9;14:1068925. doi: 10.3389/fendo.2023.1068925. eCollection 2023.
PubMed 36843581
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Protective Effect of Histamine H1 Receptor Antagonist In Patients With Severe Burns: A Clinical Study
- ClinicalTrials.gov ID
- NCT06126991
- Acronym / sponsor ID
- RuijinH_20230318
- Conditions
- Burns
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Nov 2023 (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.
This prospective clinical trial aims to investigate the organ protective effects of cetirizine in patients with severe burns.
Detailed description
This is a prospective, randomized, single-blind, parallel-controlled clinical trial. The global objective is to compare the organ protective effects of the sedation and analgesia regimen (midazolam, fentanyl) with the modified sedation and analgesia regimen (midazolam, fentanyl, cetirizine) in patients with severe burns (≥30% TBSA). Participants will receive the intervention from admission to 72 hours post-burn. Researchers will take the APACHE II scores on days 7 after admission as the main outcomes. Researchers will also take other supplementary examination results into account, including liver enzyme, myocardial enzyme, renal function, haemodynamic index, coagulation function, and pulmonary interstitial edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Modified Sedation and Analgesia Regimen Group | Experimental | Drug: Cetirizine, Drug: Midazolam and Fentanylmidazolam, fentanyl, cetirizine |
| The Sedation and Analgesia Regimen Group | Active comparator | Drug: Midazolam and Fentanylmidazolam, fentanyl |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Signed and dated informed consent form
- Commitment to comply with the procedures and cooperation during the course
- TBSA >30% and admitted within the first day after burns
- No severe compound injuries
Key exclusion criteria (10 listed)
- History of allergy to drugs in the trial
- Postoperative complications that would interfere with the observation
- Mental illness and severe heart disease, hypertension
- Serious genetic diseases
- Incomplete clinical information (unclear diagnosis, incomplete medical history, incomplete medication records, etc.)
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 |
|---|---|---|
| CetirizineOral administration of cetirizine at 10mg once daily will be used. | Drug | The Modified Sedation and Analgesia Regimen Group |
| Midazolam and FentanylMidazolam 50mg + fentanyl 300ug micro pump push will be used with a starting dose of 5ml/hour, adjusted according to the patient's level of sedation. The patient's RASS score will be maintained between -1-0 and the drug will be suspended with a blood pressure below 90/60mmHg. | Drug | The Modified Sedation and Analgesia Regimen Group, The Sedation and Analgesia Regimen Group |
Primary outcome
APACHE II on Day 7
Time frame: Day 7
Observation of APACHE II scores of patients in each group 7 days after admission. The APACHE II (Acute Physiology And Chronic Health Evaluation II) is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements. Higher scores correspond to more severe disease and a higher risk of death.
20 secondary outcomes
Urinary Output
Time frame: Day 7
Blood L-lactate
Time frame: Day 7
Base Excess (BE)
Time frame: Day 7
Oxygen Saturation
Time frame: Day 7
Stroke Volume Variation
Time frame: Day 7
Global End-Diastolic Volume
Time frame: Day 7
Central Venous Pressure
Time frame: Day 7
Stroke Volume
Time frame: Day 7
Cardiac Function Index
Time frame: Day 7
Pulmonary interstitial edema
Time frame: Day 7
SOFA Score
Time frame: Day 7
Body Temperature
Time frame: Day 7
Heart Rate
Time frame: Day 7
Respiratory Rate
Time frame: Day 7
Leukocyte Count
Time frame: Day 7
Blood CRP
Time frame: Day 7
Blood Calcitoninogen
Time frame: Day 7
Mechanical Ventilation Duration
Time frame: Day 28
Mortality
Time frame: Day 28
Sepsis Rate
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 35846468Zhang M, Yang P, Yu T, Harmsen MC, Gao M, Liu D, Shi Y, Liu Y, Zhang X. Lytic cocktail: An effective method to alleviate severe burn induced hyper-metabolism through regulating white adipose tissue browning. Heliyon. 2022 Mar 17;8(3):e09128. doi: 10.1016/j.heliyon.2022.e09128. eCollection 2022 Mar.
- Results publication: PubMed 35953455Wang J, Lu C, Zhang J, Gao M, Liu D, Yang P, Yu T, Wang X, Zhang X, Liu Y. LYTIC COCKTAIL ATTENUATES CATECHOLAMINE SURGE AFTER SEVERE BURNS BY BLOCKING HISTAMINE H1 RECEPTOR/PKA/CREB/TYROSINE HYDROXYLASE SIGNALING IN CHROMAFFIN CELLS. Shock. 2022 Aug 1;58(2):158-168. doi: 10.1097/SHK.0000000000001963. Epub 2022 Jul 24.
- Results publication: PubMed 36843581Wang J, Lu C, Liu X, Zhang G, Zhang J, Gao M, Liu D, Zhang X, Liu Y. Histamine H1 receptor antagonist attenuates catecholamine surge and organ injury after severe burns. Front Endocrinol (Lausanne). 2023 Feb 9;14:1068925. doi: 10.3389/fendo.2023.1068925. eCollection 2023.
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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.
Yan Liu principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cetirizine and Midazolam and Fentanyl in people with Burns, run by Ruijin Hospital at 1 site in China.
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 4 inclusion and 10 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 1 Feb 2024. 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 China. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yan Liu (021-64370045, rjliuyan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APACHE II on Day 7 (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06126991, which also lists 3 linked publications.
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 1 Feb 2024.