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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stem Cell Transplant Complications
• Intervention / Treatment: 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-0.003*PaO2/FiO2 +0.127*Lactate- 0.011 * Glomerular filtration rate

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Xiaohui Zhang, MD; Phone Number: +86 13522338836; Email: zhangxh@bjmu.edu.cn

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	Dead or alive at day 28 after septic shock diagnosis	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay	Days in the ICU after septic shock diagnosis	up to 1 year
90-day mortality	Dead or alive at day 90 after septic shock diagnosis	90 days
Time on ventilator	Days in need of mechanical ventilation	up to 1 year

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Shanghai Zhongshan Hospital; The Second Hospital of Hebei Medical University; The First Affiliated Hospital of Zhengzhou University; Guangzhou University of Chinese Medicine; People's Hospital of Xinjiang Uygur Autonomous Region; Peking Union Medical College; Navy General Hospital, Beijing; Shanxi Dayi Hospital; First Affiliated Hospital of Harbin Medical University; Second Hospital of Shanxi Medical University
• Investigators: Principal Investigator: Xiaohui Zhang, MD, Peking University Insititute of Hematology, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 27, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: septic shock; prognostic model; allogeneic hematopoietic stem cell transplant
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: PKUPH-model validation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual anonymised participant data will be made available to researchers upon reasonable request after termination and publication of the study.
• IPD Sharing Time Frame: After the termination and publication of the study
• IPD Sharing Access Criteria: Reasonable request by researcher based on study protocol.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No