Severe Septic Shock Complications

Identifying Risk Factors for Complications in Severe Septic Shock

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03716895

Enrollment

300

Registered

2018-10-23

Start date

2018-12-31

Completion date

2020-03-31

Last updated

2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

Severe Septic Shock, Lactate clearance, Acute Kidney Injury, Days alive and free, Ventilation-free days, Vasopressor-free days

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: 1. To look for risk factors associated with an increase risk of Hospital and ICU length of stay. 2. To look for risk factors associated with an increase risk of Acute Kidney Injury. 3. To look for risk factors associated with a decrease in days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy. 4. To look for risk factors associated with a decrease in Ventilator-free days. 5. To look for risk factors associated with a decrease in Vasopressor-free days. 6. To look for risk factors associated with an increase risk of in-hospital mortality. 7. To look for risk factors associated with an increase risk of Myocardial Infarction and myocardial injury. 8. To look for risk factors associated with an increase risk of Acute Respiratory Distress Syndrome. 9. To compare and validate different risk scores in our cohort.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Mechanical Ventilation-free days	28 days	Days free of mechanical ventilation up to day 28
Vasopressors-free days	28 days	Days free of vasopressors up to day 28
Rate of Acute Kidney Injury	28 days	Kidney Disease: Improving Global Outcomes definition
ICU length of stay	28 days	Days in ICU
Days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy	28 days	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.
Rate of In-hospital Mortality	30 days	Any cause mortality
Rate of Acute Respiratory Distress Syndrome	28 days	Berlin definition
Rate of New Atrial Fibrilation	28 days	New atrial fibrilation requiring treatment
Hospital length of stay	30 days	Days in Hospital

Countries

Spain

Contacts

Primary ContactMarc Vives, PhD, DESA

marcvives50@gmail.com+34972940200

Outcome results