Severe PneumoniaICUNCT06514781
The Application of Different Sedation Protocols in ICU Patients With Severe Pneumonia
An observational study of Severe Pneumonia, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study collected data from patients with severe pneumonia to compare the duration of mechanical ventilation under different sedation regimens in real-world settings. It also evaluated and compared the sedation success rates, hemodynamic changes, and clinical outcomes of patients with severe pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Pneumonia
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 27 Jan 2025
- 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: From February 1, 2023, to December 31, 2024, diagnosed with severe pneumonia in the Respiratory Intensive Care Unit of Xiangya Hospital, Central South University.
Who may be able to join
- (1)From February 1, 2023, to December 31, 2024, diagnosed with severe pneumonia in the Respiratory Intensive Care Unit of Xiangya Hospital, Central South University. The diagnosis of severe pneumonia is based on meeting at least one major criterion or three or more minor criteria:
- Major criteria:
- ①Infectious shock requiring vasopressor therapy despite adequate fluid resuscitation;
- ②Respiratory failure requiring tracheal intubation or mechanical ventilation.
- Minor criteria:
- Respiratory rate ≥ 30 breaths/min;
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- Oxygenation index (PaO2/FiO2) ≤ 250; ③Involvement of multiple lobes;
- Altered mental status and/or disorientation; ⑤Blood urea nitrogen ≥ 20 mg/dl (7.14 mmol/L);
- ⑥Systolic blood pressure < 90 mmHg requiring aggressive fluid resuscitation. (2)Patients receiving invasive mechanical ventilation who require continuous sedation treatment.
- (3)Age ≥ 18 years.
Who cannot join
- Allergic to routine sedative or analgesic medications.
- Patients who have not undergone sedation-agitation assessment.
- Patients transferred to another hospital during treatment.
- Patients who withdrew from active treatment or were discharged from the ICU within 72 hours after initiation of sedation.
Trial locations and contacts
1 site in 1 country.
About this study
This study collected data from patients with severe pneumonia to compare the duration of mechanical ventilation under different sedation regimens in real-world settings. It also evaluated and compared the sedation success rates, hemodynamic changes, and clinical outcomes of patients with severe pneumonia.
Read the detailed description
The study subjects were patients with severe pneumonia hospitalized in the Department of Respiratory and Critical Care Medicine at Xiangya Hospital, Central South University, from February 1, 2023 to December 31, 2024. Patients meeting all the following criteria were enrolled: (1) diagnosed with severe pneumonia; (2) receiving invasive mechanical ventilation and requiring continuous sedation treatment; (3) age ≥ 18 years. Patients were excluded if they met any of the following conditions: (1) allergic to routine sedative or analgesic medications; (2) had not undergone sedation-agitation assessment; (3) transferred to another hospital during treatment; (4) withdrew from active treatment or were discharged from the ICU within 72 hours after initiation of sedation. Data on patient demographics, laboratory tests, chest imaging, respiratory support methods, severity of illness assessments, sedative medication usage, and clinical outcomes were collected. The duration of mechanical ventilation under different sedation regimens in real-world settings was compared, and the correlation between sedation success rates, hemodynamic changes, and clinical outcomes in patients with severe pneumonia was evaluated and compared.
- Conditions
- Severe Pneumonia
- Keywords
- Severe pneumonia, Sedative
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cipepofol group | Initially use cipepofol as the sedative medication, with a continuous usage duration of more than 48 hours. | |
| Conventional group | Initially use non-cipepofol sedative medications, with a continuous usage duration of more than 48 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation duration
It was defined as the time from intubation (for patients intubated after ICU admission) or ICU admission (for patients already intubated upon ICU admission) to extubation or death, whichever occurred first.
Measured: From intubation (or ICU admission for patients already intubated at ICU admission) until extubation or death, whichever occurs first, assessed up to 90 days.
Secondary outcomes (3)
Sedation success rate
The level of sedation was assessed using the Richmond Agitation-Sedation Scale (RASS). Successful sedation was defined as the rate of achieving the target sedation level of Richmond Agitation-Sedation Scale [RASS]- 1 to - 4 in more than 90% of recorded RASS assessments.
Measured: During the continuous sedation treatment period, from the initiation to the discontinuation of continuous sedation, ICU discharge, or death (whichever comes first), assessed up to 90 days.
Length of ICU Stay
The total number of days from ICU admission to ICU discharge. For patients who die in the ICU, the length of stay is calculated as the date of death minus the date of ICU admission.
Measured: From ICU admission up to ICU discharge or death.
28-Day Survival Rate
The proportion of patients alive at 28 days after ICU admission. Vital status was assessed 28 days after ICU admission.
Measured: From ICU admission through day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Feb 2023
- Primary completion6 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe PneumoniaStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South 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
- Retrospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuanyuan Li, Doctor, Study director, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514781
- Sponsor's protocol ID
- 2024020151
- Acronym
- ICU
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used or analyzed during the current study are available from the corresponding author Dr. Juan Jiang upon reasonable request via email: drjiangjuan0923@163.com.
Publications
Li Y, Zhou H, Qin H, Yang W, Wu Y, Peng W, Jiang J. Cipepofol versus Conventional Sedation for Pneumonia Patients Receiving Mechanical Ventilation: A Real-World Retrospective Study of Effectiveness and Hemodynamic Safety. Drug Des Devel Ther. 2026 Sep 29;20:627449. doi: 10.2147/DDDT.S627449. eCollection 2026.
PubMed 42829580
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Different Sedation Protocols in ICU Patients With Severe Pneumonia
- ClinicalTrials.gov ID
- NCT06514781
- Acronym / sponsor ID
- ICU / 2024020151
- Conditions
- Severe Pneumonia
- Keywords
- Severe pneumonia, Sedative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 23 Jul 2024 (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 study collected data from patients with severe pneumonia to compare the duration of mechanical ventilation under different sedation regimens in real-world settings. It also evaluated and compared the sedation success rates, hemodynamic changes, and clinical outcomes of patients with severe pneumonia.
Detailed description
The study subjects were patients with severe pneumonia hospitalized in the Department of Respiratory and Critical Care Medicine at Xiangya Hospital, Central South University, from February 1, 2023 to December 31, 2024. Patients meeting all the following criteria were enrolled: (1) diagnosed with severe pneumonia; (2) receiving invasive mechanical ventilation and requiring continuous sedation treatment; (3) age ≥ 18 years. Patients were excluded if they met any of the following conditions: (1) allergic to routine sedative or analgesic medications; (2) had not undergone sedation-agitation assessment; (3) transferred to another hospital during treatment; (4) withdrew from active treatment or were discharged from the ICU within 72 hours after initiation of sedation. Data on patient demographics, laboratory tests, chest imaging, respiratory support methods, severity of illness assessments, sedative medication usage, and clinical outcomes were collected. The duration of mechanical ventilation under different sedation regimens in real-world settings was compared, and the correlation between sedation success rates, hemodynamic changes, and clinical outcomes in patients with severe pneumonia was evaluated and compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cipepofol group | – | –Initially use cipepofol as the sedative medication, with a continuous usage duration of more than 48 hours. |
| Conventional group | – | –Initially use non-cipepofol sedative medications, with a continuous usage duration of more than 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From February 1, 2023, to December 31, 2024, diagnosed with severe pneumonia in the Respiratory Intensive Care Unit of Xiangya Hospital, Central South University.
Key inclusion criteria (10 listed)
- (1)From February 1, 2023, to December 31, 2024, diagnosed with severe pneumonia in the Respiratory Intensive Care Unit of Xiangya Hospital, Central South University. The diagnosis of severe pneumonia is based on meeting at least one major criterion or three or more minor criteria:
- Major criteria:
- ①Infectious shock requiring vasopressor therapy despite adequate fluid resuscitation;
- ②Respiratory failure requiring tracheal intubation or mechanical ventilation.
- Minor criteria:
Key exclusion criteria (4 listed)
- Allergic to routine sedative or analgesic medications.
- Patients who have not undergone sedation-agitation assessment.
- Patients transferred to another hospital during treatment.
- Patients who withdrew from active treatment or were discharged from the ICU within 72 hours after initiation of sedation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mechanical ventilation duration
Time frame: From intubation (or ICU admission for patients already intubated at ICU admission) until extubation or death, whichever occurs first, assessed up to 90 days.
It was defined as the time from intubation (for patients intubated after ICU admission) or ICU admission (for patients already intubated upon ICU admission) to extubation or death, whichever occurred first.
3 secondary outcomes
Sedation success rate
Time frame: During the continuous sedation treatment period, from the initiation to the discontinuation of continuous sedation, ICU discharge, or death (whichever comes first), assessed up to 90 days.
Length of ICU Stay
Time frame: From ICU admission up to ICU discharge or death.
28-Day Survival Rate
Time frame: From ICU admission through day 28.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 42829580Li Y, Zhou H, Qin H, Yang W, Wu Y, Peng W, Jiang J. Cipepofol versus Conventional Sedation for Pneumonia Patients Receiving Mechanical Ventilation: A Real-World Retrospective Study of Effectiveness and Hemodynamic Safety. Drug Des Devel Ther. 2026 Sep 29;20:627449. doi: 10.2147/DDDT.S627449. eCollection 2026.
- Individual participant dataSharing planned: Undecided. The datasets used or analyzed during the current study are available from the corresponding author Dr. Juan Jiang upon reasonable request via email: drjiangjuan0923@163.com.
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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.
Yuanyuan Li, Doctor study director
Xiangya Hospital of Central South University
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 Severe Pneumonia, run by Xiangya Hospital of Central South University 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 10 inclusion and 4 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: finished, as of the sponsor's last update on 21 Sep 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical ventilation duration (time frame: From intubation (or ICU admission for patients already intubated at ICU admission) until extubation or death, whichever occurs first, assessed up to 90 days.). 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 NCT06514781, which also lists 1 linked publication.
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 21 Sep 2026.