Ventricular Dysfunction, LeftOPLNCT02972918
Preoperative levosimendán and Hip Fracture
An observational study of Ventricular Dysfunction, Left and Hip Fracture, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate whether preoperative optimization with levosimendan in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue perfusion parameters. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ventricular Dysfunction, Left, Hip Fracture
- What is being tested?
- Levosimendan
- Type of treatment
- Injection or infusion
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to 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: All the patients with chronic heart failure of any etiology with hip fracture that present an acute descompendation of their chronic heart failure and need inotropes because of the conventional treatment is not enough
Who may be able to join
- Patients due to undergo urgent of hip fracture.
- Patients with cardiac failure (EF < 45 %).
- Decompensated heart failure.
- Informed consent provided by the patient.
Who cannot join
- <18 years old
- Emergency surgery
- Serious aortic stenosis (< 1 cm2)
- Sustained ventricular tachycardia or atrial fibrillation >140
- Earlier episodes of "torsades depointes"
- Systolic blood pressure < 85 mmHg
Show all 9Show fewer
- Serious kidney failure (GFR < 30 ml/min)
- Serious liver failure (known class C Child-Pugh score)
- Allergy levosimendan
Trial locations and contacts
1 site in 1 country.
Spain1 site
Complejo Hospitalario Universitario de Canarias
San Cristóbal de La Laguna, S/C Tenerife, 38320
About this study
Official title: Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture
The purpose of this study is to evaluate whether preoperative optimization with levosimendan in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue perfusion parameters.
Read the detailed description
Hip fracture is a very predominant entity in elderly patients and it is one of the most frequent cause of admission in a hospital.
Elderly patients undergoing surgery for hip fracture have a high risk of morbidity and mortality in the postoperative. Several studies have shown that there is a high risk of cardiovascular complications in this group of patients and 3-months mortality is 15-20%. One of the causes of this high morbidity and mortality is the high incidence of chronic cardiac failure in this patients. The goal of the present study is to evaluate if the optimization of preoperative cardiac function with levosimendan in patients with left ventricular ejection fraction < 45% can improve haemodynamic and the tissue perfusion values, and reduce cardiac morbidity and mortality 3 months postoperatively.
Following written consent, the patients with left ventricular ejection fraction < 45% will be admitted in the resuscitation and anaesthesia room where they will receive a levosimendan intravenous injection undergoing a strict haemodynamic vigilance.
Before the levosimendan intravenous injection the patients firs have an echocardiography to evaluate myocardial function, NT-proBNP. Subsequently, an arterial line is inserted and optimization achieved by using this arterial line connected to a ProAQT sensor system ( PULSION , Edwards). The system uses pulse wave analysis to assess several parameters including: stroke volume index (SVI), cardiac index (CI), systemic vascular resistance index (SVRI), cardiac power index (CPI).The levosimendan will be administered like a continues injection during 24 hours (0,1 mcg/kg/min) without initial dose. Following the optimization the patients will be transferred to the operating room in the next 3 days and will come back to the resuscitation and anaesthesia room where they will stay 24 hours more if there is no any complication.
All the cardiac complications will be documented and follw-up will be done by after 30 days and 3 months postoperative.
The patients will be selected for more than 24 months.
- Conditions
- Ventricular Dysfunction, Left, Hip Fracture
- Being tested
- Levosimendan
- Medical subject headings
- Ventricular Dysfunction, Left, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
Also called Simdax.
24h preoperative infusion of levosimendan (0,1 mcg/Kg/min)
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | At least 12 hours before surgery: Infusion of levosimendan (0,1 mcg/kg/min). 24 hours of infusion without a bolus. Receives: Drug: Levosimendan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of Levosimendan on left ventricular function.
Changes of left ventricular function as assessed transthoracic.
Measured: Baseline and every 24 hours postoperative, 48 h postoperative, and 7 days and after 30 days postoperative.
Change in cardiac index
Measured through arterial pulse wave analysis. A baseline measurement is done before infusion is started
Measured: 48 hours after start of iv infusion
Secondary outcomes (12)
Changes in transport and tissue perfusion of oxygen
measured by arterial and venous blood gases
Measured: 1 to 2 day postoperative
Changes in renal function
Proportion of subjects who develop AKIN stage 1 (increase > 0.3 mg/dl or > 25% in serum creatinine from previous visit)
Measured: 1 to 7 days postoperative
Changes in NT-proBNP and troponin I
Plasma NT-proBNP levels were measured
Measured: 24 hours postoperative, 48 h postoperative, 72 h postoperative, and 168 h postoperative
Number of patients with adverse.
Development of arrhythmias
Measured: 30 days postoperative
Number of patients with adverse.
Occurence of nausea/vomiting
Measured: 30 days postoperative
Number of patients with adverse event.
Occurence of headache
Measured: 30 days postoperative
Use of high inotropes (dopamine, Norepinephrine)
during postoperative unit stay.
Measured: after 12 hours, after 48 hours and every 24 hours if still in the PO-Unit
morbidity
All cause
Measured: 3 months
Major adverse cardiovascular events
Perioperative heart failure infarction, stroke
Measured: 1st-30th postoperative day
Time on mechanical ventilation
Perioperative heart failure infarction, stroke
Measured: 1st-30th postoperative day
mortality
All cause
Measured: measured at 3 months
Perioperative mortality
All cause
Measured: 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startMay 2014
- Primary completionSep 2018
- Study completionApr 2019
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 Ventricular Dysfunction, LeftStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Principal investigator, María del Carmen Martín Lorenzo, Hospital Universitario de Canarias
- Investigators
- María del Carmen Martín Lorenzo, MD, Principal investigator, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972918
- Sponsor's protocol ID
- MML-LEV-2013-01
- Acronym
- OPL
- Status last verified
- Feb 2020
- First submitted
- 14 Nov 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D. Risk of mortality following clinical fractures. Osteoporos Int. 2000;11(7):556-61. doi: 10.1007/s001980070075.
PubMed 11069188Center JR, Nguyen TV, Schneider D, Sambrook PN, Eisman JA. Mortality after all major types of osteoporotic fracture in men and women: an observational study. Lancet. 1999 Mar 13;353(9156):878-82. doi: 10.1016/S0140-6736(98)09075-8.
PubMed 10093980Pedersen SJ, Borgbjerg FM, Schousboe B, Pedersen BD, Jorgensen HL, Duus BR, Lauritzen JB; Hip Fracture Group of Bispebjerg Hospital. A comprehensive hip fracture program reduces complication rates and mortality. J Am Geriatr Soc. 2008 Oct;56(10):1831-8. doi: 10.1111/j.1532-5415.2008.01945.x.
PubMed 19054201Ponschab M, Hochmair N, Ghazwinian N, Mueller T, Plochl W. Levosimendan infusion improves haemodynamics in elderly heart failure patients undergoing urgent hip fracture repair. Eur J Anaesthesiol. 2008 Aug;25(8):627-33. doi: 10.1017/S0265021508004080. Epub 2008 Apr 11.
PubMed 18405408
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Optimization Levosimendan in Heart Failure Patients Undergoing Hip Fracture
- ClinicalTrials.gov ID
- NCT02972918
- Acronym / sponsor ID
- OPL / MML-LEV-2013-01
- Conditions
- Ventricular Dysfunction, Left, Hip Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- May 2014 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 25 Nov 2016 (estimated)
- 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.
The purpose of this study is to evaluate whether preoperative optimization with levosimendan in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue perfusion parameters.
Detailed description
Hip fracture is a very predominant entity in elderly patients and it is one of the most frequent cause of admission in a hospital.
Elderly patients undergoing surgery for hip fracture have a high risk of morbidity and mortality in the postoperative. Several studies have shown that there is a high risk of cardiovascular complications in this group of patients and 3-months mortality is 15-20%. One of the causes of this high morbidity and mortality is the high incidence of chronic cardiac failure in this patients. The goal of the present study is to evaluate if the optimization of preoperative cardiac function with levosimendan in patients with left ventricular ejection fraction < 45% can improve haemodynamic and the tissue perfusion values, and reduce cardiac morbidity and mortality 3 months postoperatively.
Following written consent, the patients with left ventricular ejection fraction < 45% will be admitted in the resuscitation and anaesthesia room where they will receive a levosimendan intravenous injection undergoing a strict haemodynamic vigilance.
Before the levosimendan intravenous injection the patients firs have an echocardiography to evaluate myocardial function, NT-proBNP. Subsequently, an arterial line is inserted and optimization achieved by using this arterial line connected to a ProAQT sensor system ( PULSION , Edwards). The system uses pulse wave analysis to assess several parameters including: stroke volume index (SVI), cardiac index (CI), systemic vascular resistance index (SVRI), cardiac power index (CPI).The levosimendan will be administered like a continues injection during 24 hours (0,1 mcg/kg/min) without initial dose. Following the optimization the patients will be transferred to the operating room in the next 3 days and will come back to the resuscitation and anaesthesia room where they will stay 24 hours more if there is no any complication.
All the cardiac complications will be documented and follw-up will be done by after 30 days and 3 months postoperative.
The patients will be selected for more than 24 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | – | Drug: LevosimendanAt least 12 hours before surgery: Infusion of levosimendan (0,1 mcg/kg/min). 24 hours of infusion without a bolus. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients with chronic heart failure of any etiology with hip fracture that present an acute descompendation of their chronic heart failure and need inotropes because of the conventional treatment is not enough
Key inclusion criteria (4 listed)
- Patients due to undergo urgent of hip fracture.
- Patients with cardiac failure (EF < 45 %).
- Decompensated heart failure.
- Informed consent provided by the patient.
Key exclusion criteria (9 listed)
- <18 years old
- Emergency surgery
- Serious aortic stenosis (< 1 cm2)
- Sustained ventricular tachycardia or atrial fibrillation >140
- Earlier episodes of "torsades depointes"
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 |
|---|---|---|
| LevosimendanAlso: Simdax.24h preoperative infusion of levosimendan (0,1 mcg/Kg/min) | Drug | Levosimendan |
Primary outcome
The effects of Levosimendan on left ventricular function.
Time frame: Baseline and every 24 hours postoperative, 48 h postoperative, and 7 days and after 30 days postoperative.
Changes of left ventricular function as assessed transthoracic.
Change in cardiac index
Time frame: 48 hours after start of iv infusion
Measured through arterial pulse wave analysis. A baseline measurement is done before infusion is started
12 secondary outcomes
Changes in transport and tissue perfusion of oxygen
Time frame: 1 to 2 day postoperative
Changes in renal function
Time frame: 1 to 7 days postoperative
Changes in NT-proBNP and troponin I
Time frame: 24 hours postoperative, 48 h postoperative, 72 h postoperative, and 168 h postoperative
Number of patients with adverse.
Time frame: 30 days postoperative
Number of patients with adverse.
Time frame: 30 days postoperative
Number of patients with adverse event.
Time frame: 30 days postoperative
Use of high inotropes (dopamine, Norepinephrine)
Time frame: after 12 hours, after 48 hours and every 24 hours if still in the PO-Unit
morbidity
Time frame: 3 months
Major adverse cardiovascular events
Time frame: 1st-30th postoperative day
Time on mechanical ventilation
Time frame: 1st-30th postoperative day
mortality
Time frame: measured at 3 months
Perioperative mortality
Time frame: 7 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Results publication: PubMed 11069188Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D. Risk of mortality following clinical fractures. Osteoporos Int. 2000;11(7):556-61. doi: 10.1007/s001980070075.
- Results publication: PubMed 10093980Center JR, Nguyen TV, Schneider D, Sambrook PN, Eisman JA. Mortality after all major types of osteoporotic fracture in men and women: an observational study. Lancet. 1999 Mar 13;353(9156):878-82. doi: 10.1016/S0140-6736(98)09075-8.
- Results publication: PubMed 19054201Pedersen SJ, Borgbjerg FM, Schousboe B, Pedersen BD, Jorgensen HL, Duus BR, Lauritzen JB; Hip Fracture Group of Bispebjerg Hospital. A comprehensive hip fracture program reduces complication rates and mortality. J Am Geriatr Soc. 2008 Oct;56(10):1831-8. doi: 10.1111/j.1532-5415.2008.01945.x.
- Results publication: PubMed 18405408Ponschab M, Hochmair N, Ghazwinian N, Mueller T, Plochl W. Levosimendan infusion improves haemodynamics in elderly heart failure patients undergoing urgent hip fracture repair. Eur J Anaesthesiol. 2008 Aug;25(8):627-33. doi: 10.1017/S0265021508004080. Epub 2008 Apr 11.
- 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.
María del Carmen Martín Lorenzo, MD principal investigator
Hospital Universitario de Canarias
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 Ventricular Dysfunction, Left and Hip Fracture, run by Hospital Universitario de Canarias 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 5 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of Levosimendan on left ventricular function. (time frame: Baseline and every 24 hours postoperative, 48 h postoperative, and 7 days and after 30 days postoperative.). The study lists 2 primary outcomes in all. 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 NCT02972918, 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 5 Feb 2020.