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

NCT06022445 | Unknown

• 1 other identifier: PKUPH-model validation
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stem Cell Transplant Complications

Keywords

septic shock; prognostic model; allogeneic hematopoietic stem cell transplant

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  Dead or alive at day 28 after septic shock diagnosis

  28 days

Secondary Outcomes (3)

• ICU length of stay

  up to 1 year

• 90-day mortality

  90 days

• Time on ventilator

  up to 1 year

Study Arms (1)

Patients with septic shock after allo-HSCT

patients who underwent allo-HSCT and experienced septic shock

Other: CARPET prognostic model

Interventions

CARPET prognostic model OTHER

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.

Patients with septic shock after allo-HSCT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Xiaohui Zhang, MD

  Peking University Insititute of Hematology, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhang, MD

CONTACT

+86 13522338836; zhangxh@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Peking University Institute of Hematology

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: September 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 30, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After the termination and publication of the study
• Access Criteria: Reasonable request by researcher based on study protocol.

Locations

CN (1)