Septic ShockPhase 4NCT05886192
The Construction and Application of Therapeutic System of Intelligent Decision-Oriented Hemodynamic Organized Therapy for Shock Patients
A Phase 4 study testing norepinephrine+vasopressin and Norepinephrine in people with Septic Shock, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Patients with septic shock with norepinephrine >0.25ug/kg/min were enrolled. Informed consent was obtained for inclusion in the study and random assignment into the combination or norepinephrine group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- norepinephrine+vasopressin and Norepinephrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 Sep 2025
- Phase
- Phase 4
- 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
Who may be able to join
- Septic shock patients with norepinephrine>0.25ug/kg/min
Who cannot join
- Under 18 years of age
- Acute coronary syndrome requiring treatment
- have been treated with VA-ECMO
- VV-ECMO treatment has been administered for less than 12 hours
- Patient is on posterior pituitary hormone
- Patients with liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 30
Show all 13Show fewer
- Patients requiring more than 500 mg of hydrocortisone or equivalent glucocorticoid daily as a fixed dose
- absolute neutrophil counts below 1,000/mm3
- Patients with active bleeding who are expected to require (within 48 hours of study entry) transfusion of more than 4 units of red blood cell concentrate patients with active bleeding that is expected to require (within 48 hours of study entry) transfusion of more than 4 units of red blood cell concentrate
- malignancy or other irreversible disease or condition with an estimated 6-month mortality rate of ≥50%
- Confirmed or suspected acute mesenteric ischemia. If the investigator believes that the patient's condition is highly suspicious but not confirmed by conventional criteria The investigator may exclude a patient if, in the opinion of the investigator, the patient's condition is highly suspicious but not confirmed by conventional criteria, or if the treating physician has initiated empiric therapy.
- Likely death expected within 12 hours
- Family or physician plans to implement a palliative care plan for the patient
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
010-69152300
About this study
Patients with septic shock with norepinephrine >0.25ug/kg/min were enrolled. Informed consent was obtained for inclusion in the study and random assignment into the combination or norepinephrine group.
Contact the research assistant to obtain patient number information and print out the appropriate labels.Notify the ward dispensing nurse to open the experimental drug cassette (placed in the refrigerator 4℃ drug cabinet).
Read more
Extract the corresponding experimental medication according to the patient label number, dispense it and send it to the ward, label it and hand it over to the bedside nurse to start using it. The time point at which the medication was connected to the patient and activated was recorded as the zero point for the start of the study.
The data were monitored according to the time points specified in the study: baseline,0h , 6h, D1, D2, and post-drug withdrawal.
- Conditions
- Septic Shock
- Being tested
- norepinephrine+vasopressin, Norepinephrine
- Keywords
- norepinephrine, vasopressin, organ perfusion.
- Medical subject headings
- Shock, Septic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norepinephrine+vasopressinDrug
Norepinephrine combined with vasopressin to maintain blood pressure
NorepinephrineDrug
norepinephrine
| Study group | Role | What they receive |
|---|---|---|
| norepinephrine+vasopressin | Experimental | norepinephrine+vasopressin Receives: Drug: norepinephrine+vasopressin |
| Norepinephrine | Placebo comparator | norepinephrine Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
28days-Mortality in ICU
28 day mortality rate
Measured: 28 days
ICU duration
Residence time in ICU
Measured: an average of 1 year
Secondary outcomes (7)
RVDEA/LVDEA
bedside cardiac ultrasound parameters,Qualitative indicators: RVDEA/LVDEA
Measured: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
right ventricular thickness
bedside cardiac ultrasound parameters qualitative indicators: right ventricular thickness,
Measured: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Tricuspid Annular Plane Systolic Excursion
Right ventricular systolic function indicators: Tricuspid,Annular,Plane,Systolic,Excursion (TAPSE) Right ventricular pressure indicators: TV max, peak pulmonary artery regurgitation Other cardiac parameters: E/A, E/E'.
Measured: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
resistance index of superior mesenteric artery
Blood flow parameters of superior mesenteric artery: resistance index 2) VexUS: Liver vein, portal vein, and renal vein. 3) Arterial pressure monitoring waveform. 4) Intestinal ultrasound score
Measured: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
venous excess ultrasound grading system(VexUS)
Liver vein, portal vein, and renal vein.
Measured: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Intestinal ultrasound score
Intestinal ultrasound score :Including the diameter of the small intestine, the thickness of the small intestine wall, and the frequency of small intestine peristalsis
Measured: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
pulsatility index of the middle cerebral artery
Cranial ultrasound measurement indexes Cranial ultrasound measurement indexes: pulsatility index of the middle cerebral artery
Measured: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 May 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886192
- Sponsor's protocol ID
- 2022-PUMCH-B-115
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Construction and Application of Therapeutic System of Intelligent Decision-Oriented Hemodynamic Organized Therapy for Shock Patients
- ClinicalTrials.gov ID
- NCT05886192
- Acronym / sponsor ID
- 2022-PUMCH-B-115
- Conditions
- Septic Shock
- Keywords
- norepinephrine, vasopressin, organ perfusion.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 2 Jun 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.
Patients with septic shock with norepinephrine >0.25ug/kg/min were enrolled. Informed consent was obtained for inclusion in the study and random assignment into the combination or norepinephrine group.
Contact the research assistant to obtain patient number information and print out the appropriate labels.Notify the ward dispensing nurse to open the experimental drug cassette (placed in the refrigerator 4℃ drug cabinet).
Extract the corresponding experimental medication according to the patient label number, dispense it and send it to the ward, label it and hand it over to the bedside nurse to start using it. The time point at which the medication was connected to the patient and activated was recorded as the zero point for the start of the study.
The data were monitored according to the time points specified in the study: baseline,0h , 6h, D1, D2, and post-drug withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| norepinephrine+vasopressin | Experimental | Drug: norepinephrine+vasopressinnorepinephrine+vasopressin |
| Norepinephrine | Placebo comparator | Drug: Norepinephrinenorepinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Septic shock patients with norepinephrine>0.25ug/kg/min
Key exclusion criteria (13 listed)
- Under 18 years of age
- Acute coronary syndrome requiring treatment
- have been treated with VA-ECMO
- VV-ECMO treatment has been administered for less than 12 hours
- Patient is on posterior pituitary hormone
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 |
|---|---|---|
| norepinephrine+vasopressinNorepinephrine combined with vasopressin to maintain blood pressure | Drug | norepinephrine+vasopressin |
| Norepinephrinenorepinephrine | Drug | Norepinephrine |
Primary outcome
28days-Mortality in ICU
Time frame: 28 days
28 day mortality rate
ICU duration
Time frame: an average of 1 year
Residence time in ICU
7 secondary outcomes
RVDEA/LVDEA
Time frame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
right ventricular thickness
Time frame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Tricuspid Annular Plane Systolic Excursion
Time frame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
resistance index of superior mesenteric artery
Time frame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
venous excess ultrasound grading system(VexUS)
Time frame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Intestinal ultrasound score
Time frame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
pulsatility index of the middle cerebral artery
Time frame: baseline,0hour, 6hour, Day1, Day2, and post-drug withdrawal(within 1week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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Sepsis
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?
A Phase 4 study testing norepinephrine+vasopressin and Norepinephrine in people with Septic Shock, run by Peking Union Medical College 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 1 inclusion and 13 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 2 Jun 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Zhou Yuankai, MD (69152300, zhouyuankai@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28days-Mortality in ICU (time frame: 28 days). The study lists 2 primary outcomes in all. 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 2 Jun 2023.