The Stroke Volume Optimization of Goal Directed Fluid Therapy During Radical Cystectomy

Overview

Although fluid therapy is of paramount value in anesthetic practice, there is no guideline available for perioperative fluid management in major abdominal surgery. So, there is a need to establish whether goal directed fluid therapy protocol is effective during radical cystectomy and urinary diversion. A balance of perioperative fluid therapy is crucial, yet the method to achieve this equilibrium remains a highly debated subject. Therefore, this study will be designed to investigate the effects of two individualized goal directed fluid therapy during radical cystectomy to encourage an effective circulating blood volume and pressure. Accordingly, as a primary outcome, the investigators assume that stroke volume optimization could maintain better perioperative hemodynamic stability with low incidence and severity of hypotensive episodes together with achievement of maximal oxygenation. Hopefully this regimen could help to decrease the possibility of perioperative tissue hypoperfusion and the possible associated complications as a secondary outcome.

Full Title of Study: “Perioperative Goal Directed Fluid Therapy During Radical Cystectomy: the Impact of Stroke Volume Optimization vs Dynamic Central Venous Pressure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: August 1, 2020

Detailed Description

Study protocol: Patients will be randomly assigned to one of two equal groups, according to computer-generated randomization sequence into: – Stroke volume optimization group (SVO group). – Central venous pressure dynamic group(CVPdyngroup). Stroke volume optimization group (SVO group): Colloid aliquots of 200 ml 6% hydroxy ethyl starch 130/ 0.4 (Voluven, Fresenius kabi, Deutschland GmbH, Bad Homburg, Germany) will be administered within 10 minutes and stroke volume response will be recorded .If stroke volume increase by more than 10 % for 20 minutes, the aliquot will be repeated. No further aliquots will be given once stroke volume failed to increase >10%. The last stroke volume without rise of > 10% will be defined as optimum stroke volume (SVopt).When stroke volume decreases by 10% below (SVopt), this will be defined as trigger stroke volume (SVT). Stroke volume will be followed every 30 minutes during surgery and every 4 hours for 24 hours postoperatively . Central venous pressure dynamic group (CVPdyn group): Colloid aliquots of 200 ml 6% hydroxy ethyl starch 130/ 0.4(Voluven) will be administered within 10 minutes and CVP response will be recorded. If CVP failed to rise sustainably for more than 2 mmHg for 20 minutes, the aliquot will be repeated. No further aliquots will be given once CVP increases more than 2 mmHg above the recorded one.The last CVP with sustained rise of>2 mmHg will be defined as CVP maximum (CVPmax).When CVP decrease below (CVPmax)by 3 mmHg, this will be defined as trigger CVP (CVPT).CVP will be followed every 30 min during surgery and every 4 hours for 24 hours postoperatively

Interventions

  • Other: stroke volume optimization
    • Hemodynamic variables including stroke volume (SV), stroke volume variation (SVV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), thoracic fluid content (TFC), corrected flow time (FTC), index of contractility (ICON), systolic time ratio (STR), oxygen delivery (DO2) and oxygen delivery index (DO2I) will be measured by Cardiac output non-invasive monitor (ICONTM, OSYPKA medical cardiotronic GMBH, Elixir, Germany). Heart rate (HR), mean arterial blood pressure (MAP), central venous pressure (CVP) and arterial oxygen saturation (Sao2) will be measured using HP monitor. If mean arterial blood pressure(MAP) drops below 65 mmHg despite achievement of SVopt and CVPmax in both groups, a bolus dose of 5 mg ephedrine will be given and repeated as needed .Norepinephrine will be given for persistent hypotension.Dobutamine 5 mic/kg/min will be started if cardiac index less than 2.5 l/m2.

Arms, Groups and Cohorts

  • Active Comparator: Stroke volume optimization
    • Colloid aliquots of 200 ml 6% hydroxy ethyl starch 130/ 0.4 (Voluven) will be administered within 10 minutes and stroke volume response will be recorded .If stroke volume increase by more than 10 % for 20 minutes, the aliquot will be repeated.
  • Sham Comparator: Central venous pressure dynamic
    • Colloid aliquots of 200 ml 6% hydroxy ethyl starch 130/ 0.4(Voluven) will be administered within 10 minutes and CVP response will be recorded. If CVP failed to rise sustainably for more than 2 mmHg for 20 minutes, the aliquot will be repeated.

Clinical Trial Outcome Measures

Primary Measures

  • Perioperative hypotension
    • Time Frame: perioperative
    • Mean arterial blood pressure < 65mmHg
  • Maximal tissue oxygenation
    • Time Frame: perioperative
    • Oxygen delivery index > 550 ml/min/m2

Secondary Measures

  • Medical postoperative complication
    • Time Frame: 48 hours postoperative
    • Acute kidney injury (AKI) . Postoperative serum creatinine value is either more than 1.5-fold or more than 0.3 mg/dl before surgery within 48 hours
  • Surgical postoperative complication
    • Time Frame: 7-days postoperative
    • Nausea, vomiting, abdominal distension, anastomotic leakage, paralytic ileus
  • Anesthetic postoperative complication
    • Time Frame: 24 hours postoperative
    • Cardiogenic pulmonary edema.Cardiac index < 2.5 l/min/m2
  • Surgical postoperative complication
    • Time Frame: 7-days postoperative
    • Wound infection and burst abdomen
  • Respiratory postoperative complication
    • Time Frame: 7-days postoperative
    • Pneumonia, acute respiratory distress, postoperative ventilation and ICU admission.length of ICU stay in days.
  • Postoperative complication
    • Time Frame: 7-days postoperative
    • mortality

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients with American Society of Anesthesiologists (ASA) physical status I – II scheduled for radical cystectomy and urinary diversion for muscle invasive urinary bladder carcinoma . – Both sexes Exclusion Criteria:

  • Patients younger than 18 years – Body mass index (BMI) < 25 and >35. – Patients with any contraindications to epidural anesthesia (patient refusal, local skin infection, previous spine surgery and coagulopathy). – Those with known allergy to local anesthetics. – Patients with major cardiovascular problems with ejection fraction < 40 . – Renal impairment with serum creatinine >1.8 mg/dl – Patients with hepatic dysfunction will be excluded.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mahmoud Mahmoud Othman, professor of Anesthesia and surgical ICU – Mansoura University
  • Overall Official(s)
    • Mahmoud M Othman, Professor, Principal Investigator, Mansoura faculty of medicine

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