Diastolic DysfunctionREPRISSNCT03198611
Reversibility of Diastolic Disfunction in Septic Shock
An observational study of Diastolic Dysfunction and Septic Shock, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 5 sites in Spain.
Trial summary
Objectives: To study the prognostic value of the evolution of diastolic function according to fluid balance in patients admitted to the ICU with a diagnosis of septic shock, in terms of mortality (ICU and hospital) and mortality at 90 days. 2.4. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diastolic Dysfunction, Septic Shock
- What is being tested?
- Echocardiography
- How many people
- 350 participants
- Where
- 5 sitesSpain
- Study dates
- 1 Mar 2018to 1 Apr 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU with diagnosis of septic shock, and stay longer than 48h
Who may be able to join
- Patients admitted to the ICU with diagnosis of septic shock, and stay longer than 48h
Who cannot join
- No echocardiographic window
- Fatal prognosis with do not resuscitate orders at admission
- Previous history of Ischemic cardiomyopathy
- Valvular prosthesis
- Advanced degree of valvular disorder
- Advanced degree of pericardial effusion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Not yet recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Luis Zapata Fenor, MD PhD, 0034935537255, LZapata@santpau.cat
Luis Zapata Fenor, MD PhD
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Lluis Zapata, MD PhD
- Recruiting
Hospital del Mar
Barcelona
Purificacion Perez
Irene Dot
- Recruiting
Hospital del Vall d´Hebron
Barcelona
Marina Garcia
- Recruiting
Hospital Verge de la Cinta
Tortosa, Tarragona
Ferran Roche-Campo
About this study
Official title: Early Reversibility of Diastolic Disfunction as a Prognostic Factor in Septic Shock
Objectives: To study the prognostic value of the evolution of diastolic function according to fluid balance in patients admitted to the ICU with a diagnosis of septic shock, in terms of mortality (ICU and hospital) and mortality at 90 days.
2.4. Secondary objectives: A) Incidence and reversibility of myocardial dysfunction (left ventricular systolic and diastolic) in septic shock.
- Incidence and reversibility of diastolic dysfunction according to the echocardiographic criterion used.
- Incidence and reversibility of right ventricular systolic dysfunction.
- Conditions
- Diastolic Dysfunction, Septic Shock
- Being tested
- Echocardiography
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Usual echocardiographic studies in patients suffering septic shock
| Study group | Role | What they receive |
|---|---|---|
| Normal function | No systolic dysfunction No diastolic dysfunction No right ventricular dysfunction Receives: Diagnostic Test: Echocardiography | |
| Left ventricular systolic dysfunction | Left ventricular ejection fraction < 50% Receives: Diagnostic Test: Echocardiography | |
| Left ventricular diastolic dysfunction | Classification according to:
* Mitral lateral annulus e' in tissue Doppler < 10 cm/s
* American society of echocardiography (ASE) criteria 2009
* ASE criteria 2016 Receives: Diagnostic Test: Echocardiography | |
| Right ventricular dysfunction | Tricuspid annulus plane systolic excursion < 17 cm Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 90 days
Dead at 90 days
Measured: 90 days
Secondary outcomes (4)
ICU mortality
Dead in ICU
Measured: 90 days
In hospital mortality
Dead in hospital
Measured: 90 days
Incidence of myocardial disfunction
According to the criteria specified at groups section
Measured: During the first 24 hours of ICU admission
Change in incidence of diastolic dysfunction
Change in incidence of diastolic dysfunction according to the different criteria used.
Measured: From first 24 hours of ICU admission until 48h, 72h and 7 days from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Mar 2018
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198611
- Sponsor's protocol ID
- IIBSP-REP-2017-30
- Acronym
- REPRISS
- Status last verified
- Mar 2018
- First submitted
- 16 Jun 2017
- Last updated
- 6 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Suarez JC, Lopez P, Mancebo J, Zapata L. Diastolic dysfunction in the critically ill patient. Response from the authors. Med Intensiva. 2017 Apr;41(3):198. doi: 10.1016/j.medin.2016.12.008. Epub 2017 Mar 3. No abstract available. English, Spanish.
PubMed 28262372Mahjoub Y, Benoit-Fallet H, Airapetian N, Lorne E, Levrard M, Seydi AA, Amennouche N, Slama M, Dupont H. Improvement of left ventricular relaxation as assessed by tissue Doppler imaging in fluid-responsive critically ill septic patients. Intensive Care Med. 2012 Sep;38(9):1461-70. doi: 10.1007/s00134-012-2618-9. Epub 2012 Jun 21.
PubMed 22717694Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Alexandru Popescu B, Waggoner AD; Houston, Texas; Oslo, Norway; Phoenix, Arizona; Nashville, Tennessee; Hamilton, Ontario, Canada; Uppsala, Sweden; Ghent and Liege, Belgium; Cleveland, Ohio; Novara, Italy; Rochester, Minnesota; Bucharest, Romania; and St. Louis, Missouri. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1321-1360. doi: 10.1093/ehjci/jew082. Epub 2016 Jul 15. No abstract available.
PubMed 27422899
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Reversibility of Diastolic Disfunction as a Prognostic Factor in Septic Shock
- ClinicalTrials.gov ID
- NCT03198611
- Acronym / sponsor ID
- REPRISS / IIBSP-REP-2017-30
- Conditions
- Diastolic Dysfunction, Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 26 Jun 2017 (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.
Objectives: To study the prognostic value of the evolution of diastolic function according to fluid balance in patients admitted to the ICU with a diagnosis of septic shock, in terms of mortality (ICU and hospital) and mortality at 90 days.
2.4. Secondary objectives: A) Incidence and reversibility of myocardial dysfunction (left ventricular systolic and diastolic) in septic shock.
- Incidence and reversibility of diastolic dysfunction according to the echocardiographic criterion used.
- Incidence and reversibility of right ventricular systolic dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal function | – | Diagnostic Test: EchocardiographyNo systolic dysfunction No diastolic dysfunction No right ventricular dysfunction |
| Left ventricular systolic dysfunction | – | Diagnostic Test: EchocardiographyLeft ventricular ejection fraction < 50% |
| Left ventricular diastolic dysfunction | – | Diagnostic Test: EchocardiographyClassification according to: * Mitral lateral annulus e' in tissue Doppler < 10 cm/s * American society of echocardiography (ASE) criteria 2009 * ASE criteria 2016 |
| Right ventricular dysfunction | – | Diagnostic Test: EchocardiographyTricuspid annulus plane systolic excursion < 17 cm |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU with diagnosis of septic shock, and stay longer than 48h
Key inclusion criteria (1 listed)
- Patients admitted to the ICU with diagnosis of septic shock, and stay longer than 48h
Key exclusion criteria (6 listed)
- No echocardiographic window
- Fatal prognosis with do not resuscitate orders at admission
- Previous history of Ischemic cardiomyopathy
- Valvular prosthesis
- Advanced degree of valvular disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyUsual echocardiographic studies in patients suffering septic shock | Diagnostic test | Left ventricular diastolic dysfunction, Left ventricular systolic dysfunction, Normal function, Right ventricular dysfunction |
Primary outcome
Mortality at 90 days
Time frame: 90 days
Dead at 90 days
4 secondary outcomes
ICU mortality
Time frame: 90 days
In hospital mortality
Time frame: 90 days
Incidence of myocardial disfunction
Time frame: During the first 24 hours of ICU admission
Change in incidence of diastolic dysfunction
Time frame: From first 24 hours of ICU admission until 48h, 72h and 7 days from admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Background: PubMed 28262372Suarez JC, Lopez P, Mancebo J, Zapata L. Diastolic dysfunction in the critically ill patient. Response from the authors. Med Intensiva. 2017 Apr;41(3):198. doi: 10.1016/j.medin.2016.12.008. Epub 2017 Mar 3. No abstract available. English, Spanish.
- Background: PubMed 22717694Mahjoub Y, Benoit-Fallet H, Airapetian N, Lorne E, Levrard M, Seydi AA, Amennouche N, Slama M, Dupont H. Improvement of left ventricular relaxation as assessed by tissue Doppler imaging in fluid-responsive critically ill septic patients. Intensive Care Med. 2012 Sep;38(9):1461-70. doi: 10.1007/s00134-012-2618-9. Epub 2012 Jun 21.
- Background: PubMed 27422899Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Alexandru Popescu B, Waggoner AD; Houston, Texas; Oslo, Norway; Phoenix, Arizona; Nashville, Tennessee; Hamilton, Ontario, Canada; Uppsala, Sweden; Ghent and Liege, Belgium; Cleveland, Ohio; Novara, Italy; Rochester, Minnesota; Bucharest, Romania; and St. Louis, Missouri. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1321-1360. doi: 10.1093/ehjci/jew082. Epub 2016 Jul 15. No abstract available.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastolic Dysfunction and Septic Shock, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 5 sites 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 6 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 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Luis Zapata Fenor, MD PhD (0034935537255, LZapata@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 90 days (time frame: 90 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 NCT03198611, which also lists 3 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 6 Mar 2018.