Septic ShockNCT03716895
Severe Septic Shock Complications
An observational study of Septic Shock, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2018to Mar 2020
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe Septic Shock defined by requiring norepinephrine at more than 0.25mcg/kg/min
Who may be able to join
- Adults older than 18 years old admitted to ICU with Severe Septic Shock
Who cannot join
- Rejecting participation by not signing informed consent form.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Dr Josep Trueta
Girona, 17007
Marc Vives, PhD, DESA, +34972940200, marcvives50@gmail.com
Judit Lopez, MD, +34972940200, judit.lofe@gmail.com
About this study
Official title: Identifying Risk Factors for Complications in Severe Septic Shock
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
Read more
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.
- Conditions
- Septic Shock
- Keywords
- Severe Septic Shock, Lactate clearance, Acute Kidney Injury, Days alive and free, Ventilation-free days, Vasopressor-free days
- Medical subject headings
- Shock, Septic, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate clearance
Time from hospital arrival to documented serum lactate of less than or equal to 2 mmol/L
Measured: 30 days
Secondary outcomes (9)
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.
Measured: 28 days
Mechanical Ventilation-free days
Days free of mechanical ventilation up to day 28
Measured: 28 days
Vasopressors-free days
Days free of vasopressors up to day 28
Measured: 28 days
Rate of Acute Kidney Injury
Kidney Disease: Improving Global Outcomes definition
Measured: 28 days
ICU length of stay
Days in ICU
Measured: 28 days
Hospital length of stay
Days in Hospital
Measured: 30 days
Rate of In-hospital Mortality
Any cause mortality
Measured: 30 days
Rate of Acute Respiratory Distress Syndrome
Berlin definition
Measured: 28 days
Rate of New Atrial Fibrilation
New atrial fibrilation requiring treatment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Vives, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716895
- Sponsor's protocol ID
- SSS-500
- Status last verified
- Oct 2018
- First submitted
- 13 Oct 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26020231Barbar SD, Clere-Jehl R, Bourredjem A, Hernu R, Montini F, Bruyere R, Lebert C, Bohe J, Badie J, Eraldi JP, Rigaud JP, Levy B, Siami S, Louis G, Bouadma L, Constantin JM, Mercier E, Klouche K, du Cheyron D, Piton G, Annane D, Jaber S, van der Linden T, Blasco G, Mira JP, Schwebel C, Chimot L, Guiot P, Nay MA, Meziani F, Helms J, Roger C, Louart B, Trusson R, Dargent A, Binquet C, Quenot JP; IDEAL-ICU Trial Investigators and the CRICS TRIGGERSEP Network. Timing of Renal-Replacement Therapy in Patients with Acute Kidney Injury and Sepsis. N Engl J Med. 2018 Oct 11;379(15):1431-1442. doi: 10.1056/NEJMoa1803213.
PubMed 30304656Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.
PubMed 29490185McIntyre WF, Um KJ, Alhazzani W, Lengyel AP, Hajjar L, Gordon AC, Lamontagne F, Healey JS, Whitlock RP, Belley-Cote EP. Association of Vasopressin Plus Catecholamine Vasopressors vs Catecholamines Alone With Atrial Fibrillation in Patients With Distributive Shock: A Systematic Review and Meta-analysis. JAMA. 2018 May 8;319(18):1889-1900. doi: 10.1001/jama.2018.4528.
PubMed 29801010
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Risk Factors for Complications in Severe Septic Shock
- ClinicalTrials.gov ID
- NCT03716895
- Acronym / sponsor ID
- SSS-500
- Conditions
- Septic Shock
- Keywords
- Severe Septic Shock, Lactate clearance, Acute Kidney Injury, Days alive and free, Ventilation-free days, Vasopressor-free days
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe Septic Shock defined by requiring norepinephrine at more than 0.25mcg/kg/min
Key inclusion criteria (1 listed)
- Adults older than 18 years old admitted to ICU with Severe Septic Shock
Key exclusion criteria (1 listed)
- Rejecting participation by not signing informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lactate clearance
Time frame: 30 days
Time from hospital arrival to documented serum lactate of less than or equal to 2 mmol/L
9 secondary outcomes
Days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy
Time frame: 28 days
Mechanical Ventilation-free days
Time frame: 28 days
Vasopressors-free days
Time frame: 28 days
Rate of Acute Kidney Injury
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Hospital length of stay
Time frame: 30 days
Rate of In-hospital Mortality
Time frame: 30 days
Rate of Acute Respiratory Distress Syndrome
Time frame: 28 days
Rate of New Atrial Fibrilation
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Background: PubMed 26020231Venot 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.
- Background: PubMed 30304656Barbar SD, Clere-Jehl R, Bourredjem A, Hernu R, Montini F, Bruyere R, Lebert C, Bohe J, Badie J, Eraldi JP, Rigaud JP, Levy B, Siami S, Louis G, Bouadma L, Constantin JM, Mercier E, Klouche K, du Cheyron D, Piton G, Annane D, Jaber S, van der Linden T, Blasco G, Mira JP, Schwebel C, Chimot L, Guiot P, Nay MA, Meziani F, Helms J, Roger C, Louart B, Trusson R, Dargent A, Binquet C, Quenot JP; IDEAL-ICU Trial Investigators and the CRICS TRIGGERSEP Network. Timing of Renal-Replacement Therapy in Patients with Acute Kidney Injury and Sepsis. N Engl J Med. 2018 Oct 11;379(15):1431-1442. doi: 10.1056/NEJMoa1803213.
- Background: PubMed 29490185Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.
- Background: PubMed 29801010McIntyre WF, Um KJ, Alhazzani W, Lengyel AP, Hajjar L, Gordon AC, Lamontagne F, Healey JS, Whitlock RP, Belley-Cote EP. Association of Vasopressin Plus Catecholamine Vasopressors vs Catecholamines Alone With Atrial Fibrillation in Patients With Distributive Shock: A Systematic Review and Meta-analysis. JAMA. 2018 May 8;319(18):1889-1900. doi: 10.1001/jama.2018.4528.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Vives, PhD, DESA (+34972940200, marcvives50@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate clearance (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03716895, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.