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

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

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.

Study Overview

• Status: Completed
• Conditions: Radical Cystectomy
• Intervention / Treatment: Other: stroke volume optimization

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

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Dakahlia
    • Mansoura, El-Dakahlia, Egypt, +2050
      • Urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: central venous pressure dynamic
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.	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.; Other Names: central venous pressure dynamic

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical postoperative complication	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	48 hours postoperative
Surgical postoperative complication	Nausea, vomiting, abdominal distension, anastomotic leakage, paralytic ileus	7-days postoperative
Anesthetic postoperative complication	Cardiogenic pulmonary edema.Cardiac index < 2.5 l/min/m2	24 hours postoperative
Surgical postoperative complication	Wound infection and burst abdomen	7-days postoperative
Respiratory postoperative complication	Pneumonia, acute respiratory distress, postoperative ventilation and ICU admission.length of ICU stay in days.	7-days postoperative
Postoperative complication	mortality	7-days postoperative

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Mahmoud M Othman, Professor, Mansoura faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 20, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MD/17.07.27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No