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

Stem Cell Transplant Complications Clinical Trial

Official title:

Prospective Validation of CARPET Prognostic Model for Patients With Septic Shock After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06022445
• Other study ID #: PKUPH-model validation
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: Peking University People's Hospital
• Contact: Xiaohui Zhang, MD
• Phone: +86 13522338836
• Email: zhangxh[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Shock, Septic
• Stem Cell Transplant Complications

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Insititute of Hematology, Peking University People's Hospital	Beijing	Beijing

Sponsors (11)

Lead Sponsor

Collaborator

Peking University People's Hospital

First Affiliated Hospital of Harbin Medical University, Guangzhou University of Chinese Medicine, Navy General Hospital, Beijing, Peking Union Medical College, People's Hospital of Xinjiang Uygur Autonomous Region, Second Hospital of Shanxi Medical University, Shanghai Zhongshan Hospital, Shanxi Dayi Hospital, The First Affiliated Hospital of Zhengzhou University, The Second Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	Dead or alive at day 28 after septic shock diagnosis	28 days
Secondary	ICU length of stay	Days in the ICU after septic shock diagnosis	up to 1 year
Secondary	90-day mortality	Dead or alive at day 90 after septic shock diagnosis	90 days
Secondary	Time on ventilator	Days in need of mechanical ventilation	up to 1 year