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Not yet recruitingNCT06022445Updated Sep 1, 2023

Prospective Validation of CARPET Prognostic Model for Septic Shock After Allo-HSCT

An observational study in Stem Cell Transplant Complications, sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by Peking University People's Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 75 Years
Sex
All
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Study summary

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

02

Conditions studied

  • Stem Cell Transplant Complications

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Keywords

  • septic shock
  • prognostic model
  • allogeneic hematopoietic stem cell transplant
03

In context

Shock, Septic

862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 298 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • age >18 years
  • underwent allo-HSCT
  • diagnosed with septic shock

Exclusion criteria

Exclusion Criteria:

  • experienced septic shock before enrollment
  • relapsed or progressed after HSCT
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with septic shock after allo-HSCT

    patients who underwent allo-HSCT and experienced septic shock

    Other: CARPET prognostic model

Interventions

  • OtherCARPET prognostic model

    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.

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What researchers measure

Primary outcomes

  1. 28-day mortality

    Dead or alive at day 28 after septic shock diagnosis

    Time frame: 28 days

Secondary outcomes

  1. ICU length of stay

    Days in the ICU after septic shock diagnosis

    Time frame: up to 1 year

  2. 90-day mortality

    Dead or alive at day 90 after septic shock diagnosis

    Time frame: 90 days

  3. Time on ventilator

    Days in need of mechanical ventilation

    Time frame: up to 1 year

07

Study locations

1 site
  • Peking University Insititute of Hematology, Peking University People's Hospital
    Beijing, Beijing 100010, China
08

References and documents

Individual participant data

Plan to share: Yes — Individual anonymised participant data will be made available to researchers upon reasonable request after termination and publication of the study.

Supporting information: Study protocol, Sap, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06022445
Lead sponsor
Peking University People's Hospital
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
Xiao Hui Zhang (Vice president of Peking University Institute of Hematology, Peking University People's Hospital) — Principal investigator
First posted
Sep 1, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
Oct 1, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Sep 1, 2023

Study contacts

Xiaohui Zhang, MD
Contact
zhangxh@bjmu.edu.cn
+86 13522338836
Xiaohui Zhang, MD
principal investigator · Peking University Insititute of Hematology, Peking University People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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