Stem Cell Transplant ComplicationsNCT06022445
Prospective Validation of CARPET Prognostic Model for Septic Shock After Allo-HSCT
An observational study of Stem Cell Transplant Complications, run by Peking University People's Hospital at 1 site in China.
Trial summary
Validation of CARPET prognostic model for septic shock after allo-HSCT: a multicenter, prospective, and cohort study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stem Cell Transplant Complications
- What is being tested?
- CARPET prognostic model
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Dec 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We included patients diagnosed with septic shock after allo-HSCT. The clinical criteria of septic shock were sepsis as defined by suspected or documented infection and an acute increase of ≥ 2 SOFA points, together with vasopressor therapy (norepinephrine, dopamine, vasopressin, or any other vasopressor) needed to elevate mean arterial pressure ≥ 65 mmHg and lactate >2 mmol/L (18 mg/dL) despite adequate fluid resuscitation.
Who may be able to join
- age >18 years
- underwent allo-HSCT
- diagnosed with septic shock
Who cannot join
- experienced septic shock before enrollment
- relapsed or progressed after HSCT
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, 100010
About this study
Official title: Prospective Validation of CARPET Prognostic Model for Patients With Septic Shock After Allogeneic Hematopoietic Stem Cell Transplantation
Validation of CARPET prognostic model for septic shock after allo-HSCT: a multicenter, prospective, and cohort study
Read the detailed description
A clinical prognostic model named CARPET model for septic shock after allo-HSCT has been developed and internally retrospectively validated. A multicenter, prospective cohort study is planned to validate this clinical prediction model again.
The equation of the prediction model for 28-day mortality was as follows:
Probability(28-day mortality)=(exp(Y))/(1+exp(Y)) where Y=2.343+1.328* Time of septic shock- 0.085* Albumin + 0.016 * Bilirubin-0.003*PaO2/FiO2 +0.127*Lactate- 0.011 * Glomerular filtration rate
- Conditions
- Stem Cell Transplant Complications
- Being tested
- CARPET prognostic model
- Keywords
- septic shock, prognostic model, allogeneic hematopoietic stem cell transplant
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARPET prognostic modelOther
For patients diagnosed with septic shock, we obtained the information in CARPET prognostic model including time of septic shock, albumin, bilirubin, PaO2/FiO2, lactate, and GFR. We calculated the CARPET risk score and the 28-day mortality probability according to CARPET logistic regression model.
| Study group | Role | What they receive |
|---|---|---|
| Patients with septic shock after allo-HSCT | patients who underwent allo-HSCT and experienced septic shock Receives: Other: CARPET prognostic model |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Dead or alive at day 28 after septic shock diagnosis
Measured: 28 days
Secondary outcomes (3)
ICU length of stay
Days in the ICU after septic shock diagnosis
Measured: up to 1 year
90-day mortality
Dead or alive at day 90 after septic shock diagnosis
Measured: 90 days
Time on ventilator
Days in need of mechanical ventilation
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant ComplicationsStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Navy General Hospital, Beijing, Second Hospital of Shanxi Medical University, The Second Hospital of Hebei Medical University, Shanghai Zhongshan Hospital, Shanxi Dayi Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Guangzhou University of Chinese Medicine, The First Affiliated Hospital of Zhengzhou University, Peking Union Medical College, First Affiliated Hospital of Harbin Medical University
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiaohui Zhang, MD, Principal investigator, Peking University Insititute of Hematology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022445
- Sponsor's protocol ID
- PKUPH-model validation
- Status last verified
- Aug 2023
- First submitted
- 27 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual anonymised participant data will be made available to researchers upon reasonable request after termination and publication of the study.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of CARPET Prognostic Model for Patients With Septic Shock After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06022445
- Acronym / sponsor ID
- PKUPH-model validation
- Conditions
- Stem Cell Transplant Complications
- Keywords
- septic shock, prognostic model, allogeneic hematopoietic stem cell transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Navy General Hospital, Beijing, Second Hospital of Shanxi Medical University, The Second Hospital of Hebei Medical University, Shanghai Zhongshan Hospital, Shanxi Dayi Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Guangzhou University of Chinese Medicine, The First Affiliated Hospital of Zhengzhou University, Peking Union Medical College, First Affiliated Hospital of Harbin Medical University
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Sep 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.
Validation of CARPET prognostic model for septic shock after allo-HSCT: a multicenter, prospective, and cohort study
Detailed description
A clinical prognostic model named CARPET model for septic shock after allo-HSCT has been developed and internally retrospectively validated. A multicenter, prospective cohort study is planned to validate this clinical prediction model again.
The equation of the prediction model for 28-day mortality was as follows:
Probability(28-day mortality)=(exp(Y))/(1+exp(Y)) where Y=2.343+1.328* Time of septic shock- 0.085* Albumin + 0.016 * Bilirubin-0.003*PaO2/FiO2 +0.127*Lactate- 0.011 * Glomerular filtration rate
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with septic shock after allo-HSCT | – | Other: CARPET prognostic modelpatients who underwent allo-HSCT and experienced septic shock |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We included patients diagnosed with septic shock after allo-HSCT. The clinical criteria of septic shock were sepsis as defined by suspected or documented infection and an acute increase of ≥ 2 SOFA points, together with vasopressor therapy (norepinephrine, dopamine, vasopressin, or any other vasopressor) needed to elevate mean arterial pressure ≥ 65 mmHg and lactate >2 mmol/L (18 mg/dL) despite adequate fluid resuscitation.
Key inclusion criteria (3 listed)
- age >18 years
- underwent allo-HSCT
- diagnosed with septic shock
Key exclusion criteria (2 listed)
- experienced septic shock before enrollment
- relapsed or progressed after HSCT
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 |
|---|---|---|
| CARPET prognostic modelFor patients diagnosed with septic shock, we obtained the information in CARPET prognostic model including time of septic shock, albumin, bilirubin, PaO2/FiO2, lactate, and GFR. We calculated the CARPET risk score and the 28-day mortality probability according to CARPET logistic regression model. | Other | Patients with septic shock after allo-HSCT |
Primary outcome
28-day mortality
Time frame: 28 days
Dead or alive at day 28 after septic shock diagnosis
3 secondary outcomes
ICU length of stay
Time frame: up to 1 year
90-day mortality
Time frame: 90 days
Time on ventilator
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Yes. Individual anonymised participant data will be made available to researchers upon reasonable request after termination and publication of the study.
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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.
Xiaohui Zhang, MD principal investigator
Peking University Insititute of Hematology, Peking University People's Hospital
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 Stem Cell Transplant Complications, run by Peking University People's 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 3 inclusion and 2 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 Sep 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohui Zhang, MD (+86 13522338836, zhangxh@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days). 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 1 Sep 2023.