Clinical Trials Logo

Clinical Trial Summary

The study is going to be a single-centre prospective randomized trial. Patients will be randomly allocated to either control group (anesthetist-directed fluid therapy) or goal directed fluid therapy group, in which fluid therapy was guided by stoke volume (SV) algorithm with the use of Nexfin monitor. Primary outcome measures were the time to hospital discharge since surgery and the occurence of complications developed during the postoperative period. Secondary outcomes included the incidence of intraoperative hypotensive episodes (with MAP<65mmHg) in both groups and the requirement of vasoactive drugs to support blood pressure


Clinical Trial Description

The study is going to be a single-centre prospective randomized trial in elderly patients undergoing hip fracture surgery under spinal anesthesia.

Patients will be randomly allocated to either control group (anesthetist-directed fluid therapy) or goal directed fluid therapy group, in which fluid therapy was guided by stoke volume (SV) algorithm with the use of Nexfin monitor.

In patients of the control group management of the hemodynamic status will be performed in the discretion of the attending anesthesiologist, with the aim of keeping mean arterial pressure (MAP) > 65mmHg. The type and amount of delivered fluids, and vasoactive or inotropic drugs will be recorded.

In Goal Directed Fluid Therapy group, fluid management will be guided by the Nexfin monitor, based on stroke volume of the patient under continuous tracking. Baseline SV will be measured after the patients will be turned to left/right position (at which they are going to stay throughout the whole procedure) and before the implementation of regional anesthesia. Fluid challenges of 250 ml will be repeated until the SV fails to increase by 10%. At this point, preload is considered optimized and SV optimum iss defined. SV trigger is defined as SV opt - 10%. After obtaining these values, the anesthetic and surgical interventions could proceed. During surgery, N/S 250ml boluses will be administered when SV is below SV trigger. Inotropic drugs will be administered (dobutamine infusion at 0.2-10mcg/kg/min) if CO is below 3.5 L/min and vasopressors (phenylephrine bolus doses of 50-100mcg) if SV and CO are within the target range but MAP is below 65mmHg.

Primary outcome measures were the time to hospital discharge since surgery and the occurence of complications developed during the postoperative period. Secondary outcomes included the incidence of intraoperative hypotensive episodes (with MAP<65mmHg) in both groups and the requirement of vasoactive drugs to support blood pressure ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04423224
Study type Interventional
Source Attikon Hospital
Contact CHRYSANTHI BATISTAKI
Phone 00302105832371
Email chrysabatistaki@yahoo.gr
Status Recruiting
Phase N/A
Start date January 15, 2018
Completion date December 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT05285800 - To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP Phase 3
Completed NCT03348488 - Transcapillary Plasma Refill in Advanced Chronic Kidney Disease N/A
Recruiting NCT03424798 - Measuring Heart and Lung Function in Critical Care N/A
Recruiting NCT06123039 - Use of Heart-lung Interaction to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP
Recruiting NCT05015218 - Internal Jugular Vein and Spinal-induced Hypotension
Recruiting NCT03685370 - PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique N/A
Recruiting NCT05951387 - Dexmedetomidine Versus Dexmedetomidine With Ketamine in Mechanically Ventilated ARDS Patients Phase 4
Completed NCT03046784 - Non-invasive Haemodynamic Monitoring in Pregnancy
Completed NCT06249113 - Effectiveness of Continous Adjuvant Lidocaine on General Anaesthesia on Tumor Craniotomy Surgery N/A
Recruiting NCT05574855 - Evaluation of Haemodynamic in Neonates Treated With Hypothermia"
Completed NCT03395483 - Peripheral and Mesenteric Perfusion in Elective Surgical Patients