Prospective Validation of CARPET Prognostic Model for Sep... | NCT06022445

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

NCT06022445

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Sep 1, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Stem Cell Transplant Complications

Interventions

CARPET prognostic model

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Estimated

Primary Completion Date

Oct 1, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Aug 27, 2023

First Submission Date that Met QC Criteria

Aug 31, 2023

First Posted Date

Sep 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2023

Last Update Posted Date

Sep 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiao Hui Zhang, Vice president of Peking University Institute of Hematology, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Name	Class
Navy General Hospital, Beijing	OTHER
Second Hospital of Shanxi Medical University	OTHER
The Second Hospital of Hebei Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with septic shock after allo-HSCT		patients who underwent allo-HSCT and experienced septic shock	Other: CARPET prognostic model

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

experienced septic shock before enrollment
relapsed or progressed after HSCT

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaohui Zhang, MD	Contact	+86 13522338836		zhangxh@bjmu.edu.cn

Overall Officials

Name	Affiliation	Role
Xiaohui Zhang, MD	Peking University Insititute of Hematology, Peking University People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Insititute of Hematology, Peking University People's Hospital		Beijing	Beijing Municipality	100010	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code

Time Frame

After the termination and publication of the study

Access Criteria

Reasonable request by researcher based on study protocol.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

Not provided

Browse Branches

Not provided