Clinical trial NCT02479321: Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring in Patients With Hip Fracture
Official title: Efficacy of Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring to Reduce Perioperative Complications in Patients With Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Keywords: Fluid therapy
Aged
Perioperative complications
Survival
Intraoperative Goal Directed Therapy
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 568
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Crude incidence rate in Spain of hip fracture in people over 65 years was 511 cases per 100,000 in 2002. About 30% of patients die in the first year. Cardiocirculatory complications during and after surgery partly explain this high morbidity and mortality. Most patients are frail and with multicomorbidity. Goal-Directed Hemodynamic Therapy (GDT) based on noninvasive continuous monitoring of blood pressure, heart rate, oxygen saturation, cardiac output, cardiac index, stroke volume and stroke volume index can reduce perioperative complications and improve survival. The objective of our study is to assess the efficacy of a goal-directed hemodynamic therapy in reducing perioperative complications. Patients and Methods: non-randomized intervention study with a historical control and 1-year follow-up. Patients older than 64 years with non-traumatic hip fracture requiring surgical intervention. In the control group standard care was performed based on non-invasive, intermittent arterial pressure measurement, obtained every 5 minutes, continuous heart rate, and oxygen saturation. In the intervention group GDT based on noninvasive monitoring will be performed. The main outcome will be the percentage of patients with perioperative complications. Secondary outcomes: LOS and survival at 12 months of surgery.


Eligibility criteria: Inclusion Criteria:

* Hip fracture that require surgical treatment
* Agree to participate and sign informed consent

Exclusion Criteria:

* Pathological or traffic related fractures
* Anesthetic contraindication for surgery
* Refractures
* Contraindication for hemodynamic monitoring
* Physiocal less than 30 after 7 minutes
* Psychomotor agitation that prevents hemodynamic monitoring

Primary outcomes:
measure: Percentage of patients who developed intraoperative haemodynamic instability
timeFrame: Intraoperative period
Secondary outcomes:
measure: Intraoperative arrhythmias
timeFrame: Intraoperative period
measure: Postoperative complications
timeFrame: Postoperative period
measure: Hospital stay
timeFrame: Patients will be followed for the duration of hospital stay, an expected median of 11 days
measure: Survival
timeFrame: One-year survival
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial Universitària de Manresa
state: Barcelona
Study officials:
affiliation: Althaia Xarxa Assistencial Universitària de Manresa
name: Joan Bosch Sabater, MD PhD
role: STUDY_CHAIR
affiliation: Althaia Xarxa Assistencial Universitària de Manresa
name: Francesca Reguant Corominas, MD PhD
role: STUDY_CHAIR
References:
citation: Lorente JV, Reguant F, Arnau A, Borderas M, Prieto JC, Torrallardona J, Carrasco L, Solano P, Perez I, Farre C, Jimenez I, Ripolles-Melchor J, Monge MI, Bosch J. Effect of goal-directed haemodynamic therapy guided by non-invasive monitoring on perioperative complications in elderly hip fracture patients within an enhanced recovery pathway. Perioper Med (Lond). 2022 Aug 10;11(1):46. doi: 10.1186/s13741-022-00277-w.