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

NCT ID: NCT03262480

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2020-12-10

Brief Summary

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.

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

Conditions

Radical Cystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

stroke volume optimization

Intervention Type: OTHER

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.

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.

Group Type: SHAM_COMPARATOR

stroke volume optimization

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

central venous pressure dynamic

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Mahmoud Othman

professor of Anesthesia and surgical ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud M Othman, Professor

Role: PRINCIPAL_INVESTIGATOR

Mansoura faculty of medicine

Locations

Urology and nephrology center

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

MD/17.07.27

Identifier Type: -

Identifier Source: org_study_id