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

Sponsor
Peking University People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06022445
Collaborator
Navy General Hospital, Beijing (Other), Second Hospital of Shanxi Medical University (Other), The Second Hospital of Hebei Medical University (Other), Shanghai Zhongshan Hospital (Other), Shanxi Dayi Hospital (Other), People's Hospital of Xinjiang Uygur Autonomous Region (Other), Guangzhou University of Chinese Medicine (Other), The First Affiliated Hospital of Zhengzhou University (Other), Peking Union Medical College (Other), First Affiliated Hospital of Harbin Medical University (Other)
200
Enrollment
1
Location
16
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Validation of CARPET prognostic model for septic shock after allo-HSCT: a multicenter, prospective, and cohort study

Condition or Disease Intervention/Treatment Phase
  • Other: CARPET prognostic model

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-0.003PaO2/FiO2 +0.127Lactate- 0.011 * Glomerular filtration rate

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Validation of CARPET Prognostic Model for Patients With Septic Shock After Allogeneic Hematopoietic Stem Cell Transplantation
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients with septic shock after allo-HSCT

patients who underwent allo-HSCT and experienced septic shock

Other: CARPET 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.

Outcome Measures

Primary Outcome Measures

  1. 28-day mortality [28 days]

    Dead or alive at day 28 after septic shock diagnosis

Secondary Outcome Measures

  1. ICU length of stay [up to 1 year]

    Days in the ICU after septic shock diagnosis

  2. 90-day mortality [90 days]

    Dead or alive at day 90 after septic shock diagnosis

  3. Time on ventilator [up to 1 year]

    Days in need of mechanical ventilation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • age >18 years

  • underwent allo-HSCT

  • diagnosed with septic shock

Exclusion Criteria:

  • experienced septic shock before enrollment

  • relapsed or progressed after HSCT

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Insititute of Hematology, Peking University People's Hospital Beijing Beijing China 100010

Sponsors and Collaborators

  • Peking University People's Hospital
  • 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

Investigators

  • Principal Investigator: Xiaohui Zhang, MD, Peking University Insititute of Hematology, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiao Hui Zhang, Vice president of Peking University Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT06022445
Other Study ID Numbers:
  • PKUPH-model validation
First Posted:
Sep 1, 2023
Last Update Posted:
Sep 1, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiao Hui Zhang, Vice president of Peking University Institute of Hematology, Peking University People's Hospital
septic shock
prognostic model
allogeneic hematopoietic stem cell transplant
Additional relevant MeSH terms:
Shock, Septic

Study Results

No Results Posted as of Sep 1, 2023