Severe Septic Shock Complications | NCT03716895

Studies
Severe Septic Shock Complications

NCT03716895

Sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Status

Unknown status

Last Update Posted

Oct 23, 2018Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Septic Shock

Interventions

Not provided

Countries

Spain

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

Oct 2018

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

Dec 2018Estimated

Primary Completion Date

Dec 2019Estimated

Completion Date

Mar 2020Estimated

First Submitted Date

Oct 13, 2018

First Submission Date that Met QC Criteria

Oct 21, 2018

First Posted Date

Oct 23, 2018Actual

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

Oct 21, 2018

Last Update Posted Date

Oct 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marc Vives, Clinical Research Lead. Department of Anesthesiology & Critical Care, Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaPrincipal Investigator

Lead Sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Adults older than 18 years old, admitted to the ICU with a Severe Septic Shock, requiring Norepinephrine at more than 0.25mcg/kg/min, who have signed informed consent form, will be consecutively included, from december 2018 to december 2019.

The primary goal is to look for risk factors associated with an increased in lactate clearance

Secondary goals are the following:

To look for risk factors associated with an increase risk of Hospital and ICU length of stay.
To look for risk factors associated with an increase risk of Acute Kidney Injury.
To look for risk factors associated with a decrease in days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy.
To look for risk factors associated with a decrease in Ventilator-free days.
To look for risk factors associated with a decrease in Vasopressor-free days.
To look for risk factors associated with an increase risk of in-hospital mortality.
To look for risk factors associated with an increase risk of Myocardial Infarction and myocardial injury.
To look for risk factors associated with an increase risk of Acute Respiratory Distress Syndrome.
To compare and validate different risk scores in our cohort.

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

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lactate clearance	Time from hospital arrival to documented serum lactate of less than or equal to 2 mmol/L	30 days

Secondary Outcomes

Measure	Description	Time Frame
Days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy	Number of days from the last day free of vasopressors, mechanical ventilation and Renal Replacement Therapy up to day 28. If patients dies it scores 0.	28 days
Mechanical Ventilation-free days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults older than 18 years old admitted to ICU with Severe Septic Shock

Exclusion Criteria:

Rejecting participation by not signing informed consent form.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Severe Septic Shock defined by requiring norepinephrine at more than 0.25mcg/kg/min

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marc Vives, PhD, DESA	Contact	+34972940200		marcvives50@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari Dr Josep Trueta		Girona		17007	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26020231	Background	Venot M, Weis L, Clec'h C, Darmon M, Allaouchiche B, Goldgran-Toledano D, Garrouste-Orgeas M, Adrie C, Timsit JF, Azoulay E. Acute Kidney Injury in Severe Sepsis and Septic Shock in Patients with and without Diabetes Mellitus: A Multicenter Study. PLoS One. 2015 May 28;10(5):e0127411. doi: 10.1371/journal.pone.0127411. eCollection 2015.
30304656

ID	Term
D012772	Shock, Septic
D058186	Acute Kidney Injury

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