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

NCT03262480 | Completed DMC

• 1 other identifier: MD/17.07.27
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Radical Cystectomy

Outcome Measures

Primary Outcomes (2)

• Perioperative hypotension

  Mean arterial blood pressure \< 65mmHg

  perioperative

• Maximal tissue oxygenation

  Oxygen delivery index \> 550 ml/min/m2

  perioperative

Secondary Outcomes (6)

• Medical postoperative complication

  48 hours postoperative

• Surgical postoperative complication

  7-days postoperative

• Anesthetic postoperative complication

  24 hours postoperative

• Surgical postoperative complication

  7-days postoperative

• Respiratory postoperative complication

  7-days postoperative

Study Arms (2)

Stroke volume optimization

ACTIVE COMPARATOR

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

Central venous pressure dynamic

SHAM COMPARATOR

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

Interventions

stroke volume optimization 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.

Also known as: central venous pressure dynamic

Central venous pressure dynamic; Stroke volume optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and nephrology center

Al Mansurah, Dakahlia Governorate, +2050, Egypt

Location

Study Officials

• Mahmoud M Othman, Professor

  Mansoura faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The management will be carried out by a member of research team only aware of allocation group. The attending anesthesiologist, surgeons and nursing staff will be totally blind of randomization schedule or the hydration regimen used. All postoperative clinical staff handling patient care will be also unaware of the aim of the work.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Anesthesia and surgical ICU

Model Details: Two groups: * Stroke volume optimization group (SVO group). * Central venous pressure dynamic group(CVPdyngroup).

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 25, 2017
• Study Start: September 1, 2017
• Primary Completion: August 1, 2020
• Study Completion: December 10, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

EG (1)