Health TrialsbyHealthPanel

Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)

ConditionsEchocardiographyHip FracturesRisk AssessmentAnesthesiaHemodynamic Instability
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUmeå University

About this trial

The primary objective of this study is to investigate the impact of preoperative focused transthoracic ultrasound (FOCUS) on intraoperative hypotension and postoperative complications in hip fracture surgery. Our hypothesis is that a preoperative FOCUS along with a hemodynamic optimization protocol will reduce the occurrence of intraoperative drops in blood pressure and post-operative complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥ 65 years of age, with American Socieity of Anesthesiologists (ASA) physical status classification 2-4, that are scheduled for acute hip fracture surgery (ICD-codes s72.0, s72.00, s72.01, s72.1, s72.2)

Disqualifiers

Metastatic cancer and/or suspect pathological fracture.

Concurrent other fracture/surgery.

Reoperation within 72 hours from primary operation.

Severe dementia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • FOCUS echocardiography

    Diagnostic test

    Preoperative FOCUS echocardiography. Based on FOCUS information: correction of low level of venous return and/or step-up monitoring and/or vasoactive drugs

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Standard managementNo intervention 0 interventions
Group B: FOCUS optimizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Blood pressure drop

Intraoperative drop in blood pressure defined as mean arterial pressure (MAP) \< 60 mmHg

Time frame
From date of randomization up to 4 hours

Secondary outcomes

1

Change of blood pressure level

Blood pressure (MAP) change from baseline BP

Time frame
From date of randomization up to 4 hours
2

Lowest level of blood pressure (MAP)

Absolut lowest blood pressure (MAP) from baseline BP

Time frame
From date of randomization up to 4 hours
3

Acute kidney failure

Acute kidney damage defined as a raise in serum creatinine according to the KDIGO-criteria

Time frame
From date of randomization up to 48 hours
4

Myocardial injury

Myocardial injury defined as a raise in serum high-sensitive troponin with at least 5 ng/l-1 to a minimum concentration of at least 20 ng/l-1

Time frame
From date of randomization up to 48 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Umeå University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: