Mechanically Ventilated Patients With ShockNCT07037615
The Impact of Different Sedation Regimens on Hemodynamics in Patients Undergoing Mechanical Ventilation With Shock
An observational study of Mechanically Ventilated Patients With Shock, run by Peking University People's Hospital.
Trial summary
Mechanical ventilation is a common therapeutic intervention in the intensive care unit (ICU). However, patients undergoing mechanical ventilation often experience agitation, unplanned extubation, patient-ventilator asynchrony, and even neuroendocrine-immune dysregulation, sympathetic overexcitation, and organ… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated Patients With Shock
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The cohort will be selected from a tertiary hospital
Who may be able to join
- Age ≥ 18 years;
- Receiving invasive mechanical ventilation, with endotracheal intubation -performed <12 hours before enrollment;
- Patient requiring sedative and analgesic medications;
- Hemodynamic instability: Hypotension (systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) occurring within 6 hours before intubation to 6 hours after intubation, requiring continuous vasoactive medication therapy for >1 hour.
Who cannot join
- Pregnant or breastfeeding patients;
- Patients with confirmed or suspected acute primary brain pathology (e.g., traumatic brain injury, intracranial hemorrhage, stroke, hypoxic brain injury);
- Patients with confirmed or suspected spinal cord injury or other pathologies likely to cause permanent or prolonged weakness;
- Patients with known allergy to the analgesic, sedative, or vasoactive medications used in the study protocol;
- Patients receiving palliative care or with an expected survival of ≤48 hours; Patients previously enrolled in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Mechanical ventilation is a common therapeutic intervention in the intensive care unit (ICU). However, patients undergoing mechanical ventilation often experience agitation, unplanned extubation, patient-ventilator asynchrony, and even neuroendocrine-immune dysregulation, sympathetic overexcitation, and organ dysfunction due to discomfort and pain. Sedation therapy mitigates patient stress, enhances comfort, and ensures the smooth implementation of mechanical ventilation, making it an essential component of treatment for ventilated patients. Nevertheless, sedation may impact peripheral vascular tone, leading to hemodynamic instability and exacerbating inadequate peripheral perfusion.
The precise implementation of sedation therapy to minimize adverse effects remains unclear. This prospective observational study will enroll critically ill patients with shock requiring mechanical ventilation. We will examine the effects of different sedation strategies-including sedation assessment protocols, sedative types, sedation duration, and daily awakening trials-on hemodynamics in this population. The study aims to explore optimized sedation regimens and provide evidence-based guidance for precision sedation therapy in clinical practice.
Read the detailed description
Critically ill patients requiring mechanical ventilation in the ICU frequently present with concurrent shock. The hemodynamic effects of sedative agents may further exacerbate circulatory instability. Studies indicate that 34% of ICU patients require simultaneous mechanical ventilation and vasoactive agent support. Among ARDS patients, over 60% develop shock, with approximately 65% necessitating vasopressor administration.
Common sedatives like propofol and dexmedetomidine, despite being first-line choices, exhibit significant hemodynamic side effects:
- Propofol induces hypotension (incidence: 20%) through vasodilation, sympathetic suppression, and bradycardia.
- Dexmedetomidine causes hypotension and bradycardia at low doses, while triggering vasoconstriction via peripheral α-2 receptor activation at high doses-both scenarios reduce cardiac output.
Additional factors affecting hemodynamic stability include sedation depth, duration, and daily awakening protocols. Deep sedation may mask dynamic assessment of fluid responsiveness, delaying shock resuscitation. Conversely, daily awakening-though reducing ventilation duration-may increase circulatory fluctuations through stress responses. These complex interactions necessitate balancing sedation efficacy and circulatory stability in shock patients, yet standardized protocols for this population remain lacking.
- Keywords
- Mechanically ventilated patients with shock, Sedation, Hemodynamics
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 |
|---|---|---|
| Cumulative vasoactive support duration <1 hour/24h | On day 28 after ICU admission, patients were assessed for vasoactive drug independence, defined as vasoactive drug infusion not exceeding 60 minutes within any continuous 24-hour window. | |
| Cumulative vasoactive support duration >1 hour/24h | On day 28 of ICU admission or thereafter, the patient underwent a vasoactive drug dependence assessment, defined as vasoactive drug infusion time exceeding 60 minutes within any continuous 24-hour window. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day vasoactive drug-free duration
Measured: The observation period commenced upon enrollment and continued for 7 days or until ICU discharge, whichever occurred first.
Secondary outcomes (7)
Cumulative vasoactive drug dose during the first 7 days post-enrollment
Measured: The observation period commenced upon enrollment and continued for 7 days or until ICU discharge, whichever occurred first.
Incidence of new-onset organ failure (respiratory/circulatory/renal) within 7 days
Measured: The observation period commenced upon enrollment and continued for 7 days or until ICU discharge, whichever occurred first.
7-day sedation goal attainment rate
Measured: 7-day sedation goal attainment rate
28-day all-cause mortality
Measured: 28-day all-cause mortality
ICU-free days within 28 days
Measured: ICU-free days are calculated as 28 days minus the total number of days (or partial days) spent in the ICU. All patients who die before day 28 or prior to ICU discharge are assigned 0 ICU-free days.
Delirium duration within 28 days，Incidence of delirium
Measured: Delirium duration is defined as the number of days the patient was alive and had documented delirium. For patients discharged from the ICU before day 28, no further delirium assessments were conducted outside the ICU.
Ventilator-free days within 28 days
Measured: Ventilator-free days (VFDs) within 28 days are defined as the number of days the patient was alive and free from invasive mechanical ventilation for at least 48 consecutive hours (successful extubation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated Patients With ShockStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shu, Peking University People's Hospital
- Investigators
- Shu Li, doctor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037615
- Sponsor's protocol ID
- 2025-Z-44
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD，all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Sedation Regimens on Hemodynamics in Patients Undergoing Mechanical Ventilation With Shock
- ClinicalTrials.gov ID
- NCT07037615
- Acronym / sponsor ID
- 2025-Z-44
- Keywords
- Mechanically ventilated patients with shock, Sedation, Hemodynamics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Jun 2025 (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.
Mechanical ventilation is a common therapeutic intervention in the intensive care unit (ICU). However, patients undergoing mechanical ventilation often experience agitation, unplanned extubation, patient-ventilator asynchrony, and even neuroendocrine-immune dysregulation, sympathetic overexcitation, and organ dysfunction due to discomfort and pain. Sedation therapy mitigates patient stress, enhances comfort, and ensures the smooth implementation of mechanical ventilation, making it an essential component of treatment for ventilated patients. Nevertheless, sedation may impact peripheral vascular tone, leading to hemodynamic instability and exacerbating inadequate peripheral perfusion.
The precise implementation of sedation therapy to minimize adverse effects remains unclear. This prospective observational study will enroll critically ill patients with shock requiring mechanical ventilation. We will examine the effects of different sedation strategies-including sedation assessment protocols, sedative types, sedation duration, and daily awakening trials-on hemodynamics in this population. The study aims to explore optimized sedation regimens and provide evidence-based guidance for precision sedation therapy in clinical practice.
Detailed description
Critically ill patients requiring mechanical ventilation in the ICU frequently present with concurrent shock. The hemodynamic effects of sedative agents may further exacerbate circulatory instability. Studies indicate that 34% of ICU patients require simultaneous mechanical ventilation and vasoactive agent support. Among ARDS patients, over 60% develop shock, with approximately 65% necessitating vasopressor administration.
Common sedatives like propofol and dexmedetomidine, despite being first-line choices, exhibit significant hemodynamic side effects:
- Propofol induces hypotension (incidence: 20%) through vasodilation, sympathetic suppression, and bradycardia.
- Dexmedetomidine causes hypotension and bradycardia at low doses, while triggering vasoconstriction via peripheral α-2 receptor activation at high doses-both scenarios reduce cardiac output.
Additional factors affecting hemodynamic stability include sedation depth, duration, and daily awakening protocols. Deep sedation may mask dynamic assessment of fluid responsiveness, delaying shock resuscitation. Conversely, daily awakening-though reducing ventilation duration-may increase circulatory fluctuations through stress responses. These complex interactions necessitate balancing sedation efficacy and circulatory stability in shock patients, yet standardized protocols for this population remain lacking.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cumulative vasoactive support duration <1 hour/24h | – | –On day 28 after ICU admission, patients were assessed for vasoactive drug independence, defined as vasoactive drug infusion not exceeding 60 minutes within any continuous 24-hour window. |
| Cumulative vasoactive support duration >1 hour/24h | – | –On day 28 of ICU admission or thereafter, the patient underwent a vasoactive drug dependence assessment, defined as vasoactive drug infusion time exceeding 60 minutes within any continuous 24-hour window. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will be selected from a tertiary hospital
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Receiving invasive mechanical ventilation, with endotracheal intubation -performed <12 hours before enrollment;
- Patient requiring sedative and analgesic medications;
- Hemodynamic instability: Hypotension (systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) occurring within 6 hours before intubation to 6 hours after intubation, requiring continuous vasoactive medication therapy for >1 hour.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding patients;
- Patients with confirmed or suspected acute primary brain pathology (e.g., traumatic brain injury, intracranial hemorrhage, stroke, hypoxic brain injury);
- Patients with confirmed or suspected spinal cord injury or other pathologies likely to cause permanent or prolonged weakness;
- Patients with known allergy to the analgesic, sedative, or vasoactive medications used in the study protocol;
- Patients receiving palliative care or with an expected survival of ≤48 hours; Patients previously enrolled in this study.
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
28-day vasoactive drug-free duration
Time frame: The observation period commenced upon enrollment and continued for 7 days or until ICU discharge, whichever occurred first.
7 secondary outcomes
Cumulative vasoactive drug dose during the first 7 days post-enrollment
Time frame: The observation period commenced upon enrollment and continued for 7 days or until ICU discharge, whichever occurred first.
Incidence of new-onset organ failure (respiratory/circulatory/renal) within 7 days
Time frame: The observation period commenced upon enrollment and continued for 7 days or until ICU discharge, whichever occurred first.
7-day sedation goal attainment rate
Time frame: 7-day sedation goal attainment rate
28-day all-cause mortality
Time frame: 28-day all-cause mortality
ICU-free days within 28 days
Time frame: ICU-free days are calculated as 28 days minus the total number of days (or partial days) spent in the ICU. All patients who die before day 28 or prior to ICU discharge are assigned 0 ICU-free days.
Delirium duration within 28 days，Incidence of delirium
Time frame: Delirium duration is defined as the number of days the patient was alive and had documented delirium. For patients discharged from the ICU before day 28, no further delirium assessments were conducted outside the ICU.
Ventilator-free days within 28 days
Time frame: Ventilator-free days (VFDs) within 28 days are defined as the number of days the patient was alive and free from invasive mechanical ventilation for at least 48 consecutive hours (successful extubation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Yes. all collected IPD，all IPD that underlie results in a publication
Related trials for Mechanically Ventilated Patients With Shock
Recruiting
Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock
Septic Shock
RecruitingObservational study
Association Between EIT and CT During PEEP Titration in Patients With Acute Respiratory Failure
Acute Hypoxemic Respiratory Failure, Ventilation, Mechanical
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.
Shu Li, doctor principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanically Ventilated Patients With Shock, run by Peking University People's Hospital.
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 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: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu Li, doctor (+86 010 88324480, lishu2401@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day vasoactive drug-free duration (time frame: The observation period commenced upon enrollment and continued for 7 days or until ICU discharge, whichever occurred first.). 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 9 Jul 2025.