Metabolomic in Critical Ill Patients | NCT01506674

Studies
Metabolomic in Critical Ill Patients

NCT01506674

Sponsor

Università Vita-Salute San Raffaele

Status

Terminated

Last Update Posted

Jan 18, 2024Actual

Enrollment

94Actual

Phase

Not provided

Conditions

Metabolomic

Interventions

Not provided

Countries

Italy

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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was terminated prematurely due to slow recruitment.

Expanded Access Info

Start Date

Jan 27, 2015Actual

Primary Completion Date

Oct 31, 2017Actual

Completion Date

Apr 6, 2023Actual

First Submitted Date

Jan 9, 2012

First Submission Date that Met QC Criteria

Jan 9, 2012

First Posted Date

Jan 10, 2012Estimated

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

Jan 16, 2024

Last Update Posted Date

Jan 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giovanni Landoni, MD, Associate Professor, Università Vita-Salute San RaffaelePrincipal Investigator

Lead Sponsor

Università Vita-Salute San RaffaeleOTHER

Collaborators

Not provided

Description Module

Brief Summary

Analysis of blood, urinary, and intrathecal metabolites of critical ill patients will be checked for possible correlations between metabolomics patterns and patients' outcomes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

94Actual

Label	Type	Description	Intervention Names
criticall ill patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Metabolomic patterns to identify poor outcome		hospital stay (approximately two weeks)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with severe left or right ventricular dysfunction undergoing cardiac surgery
patients undergoing ablation of ventricular tachycardia
patients with febrile neutropenia after chemotherapy or allogeneic transplant for haematological diseases
patients undergoing thoracoabdominal vascular surgery

Exclusion Criteria:

pregnant women
no written consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Critical ill patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Università Vita-Salute San Raffaele		Milan	Mi	20132	Italy