NCT02972918

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

4.3 years

First QC Date

November 14, 2016

Last Update Submit

February 3, 2020

Conditions

Ventricular Dysfunction, LeftHip Fracture

Outcome Measures

Primary Outcomes (2)

  • The effects of Levosimendan on left ventricular function.

    Changes of left ventricular function as assessed transthoracic.

    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

    48 hours after start of iv infusion

Secondary Outcomes (12)

  • Changes in transport and tissue perfusion of oxygen

    1 to 2 day postoperative

  • Changes in renal function

    1 to 7 days postoperative

  • Changes in NT-proBNP and troponin I

    24 hours postoperative, 48 h postoperative, 72 h postoperative, and 168 h postoperative

  • Number of patients with adverse.

    30 days postoperative

  • Number of patients with adverse.

    30 days postoperative

  • +7 more secondary outcomes

Study Arms (1)

Levosimendan

At least 12 hours before surgery: Infusion of levosimendan (0,1 mcg/kg/min). 24 hours of infusion without a bolus.

Drug: Levosimendan

Interventions

LevosimendanDRUG

24h preoperative infusion of levosimendan (0,1 mcg/Kg/min)

Also known as: Simdax.
Levosimendan

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Patients due to undergo urgent of hip fracture.
  • Patients with cardiac failure (EF \< 45 %).
  • Decompensated heart failure.
  • Informed consent provided by the patient.

You may not qualify if:

  • \<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
  • Serious kidney failure (GFR \< 30 ml/min)
  • Serious liver failure (known class C Child-Pugh score)
  • Allergy levosimendan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario Universitario de Canarias

San Cristóbal de La Laguna, S/C Tenerife, 38320, Spain

Location

Related Publications (4)

  • 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.

    PMID: 11069188RESULT

  • Center 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.

    PMID: 10093980RESULT

  • Pedersen 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.

    PMID: 19054201RESULT

  • Ponschab 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.

    PMID: 18405408RESULT

MeSH Terms

Conditions

Ventricular Dysfunction, LeftHip Fractures

Interventions

Simendan

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • María del Carmen Martín Lorenzo, MD

    Hospital Universitario de Canarias

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 25, 2016

Study Start

May 1, 2014

Primary Completion

September 1, 2018

Study Completion

April 1, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

ES(1)