NCT06126991

Brief Summary

This prospective clinical trial aims to investigate the organ protective effects of cetirizine in patients with severe burns.

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
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2024

Typical duration for phase_1

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

First Submitted

Initial submission to the registry

October 30, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 23, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 1, 2024

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 30, 2023

Last Update Submit

January 30, 2024

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 7

Secondary Outcomes (20)

  • Urinary Output

    Day 7

  • Blood L-lactate

    Day 7

  • Base Excess (BE)

    Day 7

  • Oxygen Saturation

    Day 7

  • Stroke Volume Variation

    Day 7

  • +15 more secondary outcomes

Study Arms (2)

The Modified Sedation and Analgesia Regimen Group

EXPERIMENTAL

midazolam, fentanyl, cetirizine

Drug: CetirizineDrug: Midazolam and Fentanyl

The Sedation and Analgesia Regimen Group

ACTIVE COMPARATOR

midazolam, fentanyl

Drug: Midazolam and Fentanyl

Interventions

CetirizineDRUG

Oral administration of cetirizine at 10mg once daily will be used.

The Modified Sedation and Analgesia Regimen Group
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.

The Modified Sedation and Analgesia Regimen GroupThe Sedation and Analgesia Regimen Group

Eligibility Criteria

Age12 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Malignant tumors
  • Organ insufficiency due to previous chronic diseases such as hypertension, diabetes mellitus or non-burning factors
  • Serious adverse reactions
  • Self-requested withdrawal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Burn, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 35846468BACKGROUND

  • Wang 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.

    PMID: 35953455RESULT

  • Wang 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.

    PMID: 36843581RESULT

MeSH Terms

Conditions

Burns

Interventions

CetirizineMidazolamFentanyl

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPiperidines

Study Officials

  • Yan Liu

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Liu

CONTACT

021-64370045rjliuyan@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 13, 2023

Study Start

January 23, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

February 1, 2024

Record last verified: 2023-10

Locations

CN(1)