Clinical Trials Logo

Clinical Trial Summary

The aim of the study of patients undergoing major hepatic resection was compared standard perioperative (control Group) with hemodinamic management based on PPV, VVS, continuos CO trending and dynamic arterial elastance using radial artery pulse contour analysis (GDHT group). We hypothessized that following this treatment regimen after hepatic resection results in reduced postoperative complications (primary endpoint) and reduced length of hospital stay (secundary endpoint)


Clinical Trial Description

The study was performed as a prospective randomized trial at the Department of Anesthesiology and Intensive Care Medicine and the Department of Surgery of the Hospital Universitario de Ciudad Real, Spain.Faculty. The study was approved by the local ethical committee. All patients scheduled for hepatic resection of more than two segments were found eligible for study inclusion. Exclusion criteria were: age less than 18, body weight less than 50 kg or more than 150 kg, irregular heart rhythm, severe cardiovascular disease (chronic heart failure, valvular abnormality, cardiomyopathy, etc.), severe liver dysfunction (Child Pugh score B or C). All participants signed informed consent prior study inclusion.

Protocol of the study.

Eligible patients were equally randomized into two study groups: 1) Standard perioperative (Control group ) and 2) hemodinamic management based using radial artery pulse contour analysis (GDHT group). Randomization was performed the day before surgery by the study member responsable for anesthesia delivery using sealed opaque envelope technique stored in non-transparent containers with group allocation in a 1:1 ratio. Only patients were blinded to group allocation. Care providers and investigators could not be blinded due to the presence of the cardiac index trending monitor.

Intraoperative management.

All subjects received balanced anaesthesia, i.v. anaesthetic induction, and neuromuscular relaxants; for pragmatic reasons, their administration was at the discretion of the anaesthetist. Bispectral index monitoring was used to monitor the depth of anaesthesia. Sevoflurane was used for anaesthesia maintenance, with a BIS target range of 40-60. Central venous catheter placement and invasive radial arterial blood pressure monitoring were performed per preference of the anaesthetist.

All subjects had basic anaesthetic monitoring with fivelead ECG, pulse oximetry, and oscillometric blood pressure; at least one peripheral i.v. line was established. All subjects received standard measures to maintain oxygen saturation by pulse oximetry >94%, normothermia, and heart rate <100 beats min-1. Ventilation with inspired oxygen fraction of 60% was mechanically controlled to maintain PaCO2 between 4.7 and 6.0 kPa, with a positive end-expiratory pressure of 4-6mm Hg and tidal volume of 6-8 ml kg-1.

In cases when PM was used, hemodynamic data were recorded one minute before the clamp, one minute after the clamp and one minute afterthe PM's release. Ephedrine was given in case of hemodynamic instability (mean arterial pressure <65 mmHg) and if repeated boluses were ineffective, noradrenaline infusion was started.

In a case of acute blood loss (more than 150 mL/ min or more than 500 mL), colloid infusion of was administered with respect to maximal recommended dose (30 mL/kg).

In both groups, blood loss was compensated for by infusión of colloid in a 1:1 ratio. Packed red cells were transfused for haemoglobin <10 g dl-1 in subjects with cardiac comorbidities, or <7 g dl-1 in those without cardiac comorbidities.

Hemodynamic data were documented every 15 minutes. At the beginning of hepatic resection, middle and at the end of surgery blood samples were drawn for arterial and central venous blood gas analysis. At the end of surgery total catecholamine administration, estimated blood loss, urine output and infused fluids were recorded. The time between the end of surgery and extubation was recorded.

GDHT group.

The arterial line was additionally connected to the cardiac index trending monitor (ProAQT, PULSION Medical Systems SE, Munich, Germany).

Fluid therapy was given. Before hepatic resection (Static phase) all patiens received continuous infusion of balanced crystalloid fluids (Ringer,s lactate) at 1 ml kg-1h-1 After hepatic resection (Dynamic phase), the patients received an initial hemodynamic assessment based on PPV, CI and MAP, as shown in Figure 1. First, preload was optimized by fluid loading until PPV was <14% or VVS <12%, subjects were given 4 ml kg-1 boluses colloid solution every 5 minutes. At this point, the patient's individual preload optimized CI was determined and used as the hemodynamic goal until the end of surgery. Only if this value was below 2.5 L/min/(m2), inotropes were applied to reach this minimum CI, serving as a safety parameter to prevent patients from low cardiac output. If PPV and CI were within the target range but MAP was below 65 mmHg or PPV/VVS>1,2, vasopressors were started. After the initial assessment, patients were reassessed every 15 minutes intraoperatively to maintain values ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04517409
Study type Interventional
Source Castilla-La Mancha Health Service
Contact
Status Completed
Phase N/A
Start date November 5, 2015
Completion date November 5, 2017

See also
  Status Clinical Trial Phase
Completed NCT04972266 - The EU Hyprotect Registry
Not yet recruiting NCT03691103 - Record and Analyze the Data of Patient Undergoing Anesthesia for Laparoscopic Cholecystectomy From Patient Monitoring Instruments
Active, not recruiting NCT04281771 - Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI N/A
Recruiting NCT05543824 - Hemodynamic Impact of Epidural Anesthesia in Relation to Age in Pediatric Patients.
Terminated NCT03208023 - RESIPI for Reducing Perioperative Major Adverse Cardiac Events N/A
Not yet recruiting NCT00966147 - Advanced Hemodynamic Monitoring for Goal-directed Hemodynamic Management During Radical Cystectomy N/A
Recruiting NCT05445037 - Hemodynamic and Cerebral Effects Evaluation in Anesthesia N/A
Terminated NCT02950649 - Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Perioperative Care
Completed NCT04648293 - Starling Registry Study
Completed NCT04535115 - Tidal Volume Challenge and Lung Recruitment Maneuver (TIDALREC): the Reliability of Pulse Pression Variation or Stroke Volume Variation on Fluid Responsiveness. N/A
Recruiting NCT05418881 - Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients (MONITOR) N/A
Completed NCT05779683 - Caretaker in the Cardiovascular Intensive Care Unit (CVICU)
Terminated NCT04996420 - Goal Directed Fluid Therapy Versus Liberal Fluid Regimen in Primary Elective Hip Artrhoplasty N/A
Recruiting NCT02156856 - Stroke Volume Analysis During Aortic Valve Replacement Trial N/A
Completed NCT00624494 - Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery N/A
Recruiting NCT04109339 - Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy N/A
Completed NCT04241926 - Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic Measurement by Transpulmonary Thermodilution. N/A
Completed NCT05365113 - Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients N/A
Completed NCT03893513 - Comparison of Transthoracic Electrical Bioimpedance and Pulse Contour Analysis in Renal Transplantation Patients
Recruiting NCT05930600 - Internal Jugular Venous Distensibility Index and Innominate Venous Flow Patterns as Predictors of Fluid Responsiveness