Radical Cystectomy Clinical Trial
Official title:
Perioperative Goal Directed Fluid Therapy During Radical Cystectomy: the Impact of Stroke Volume Optimization vs Dynamic Central Venous Pressure
Verified date | December 2020 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 172 |
Est. completion date | December 10, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Urology and nephrology center | Mansoura | El-Dakahlia |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perioperative hypotension | Mean arterial blood pressure < 65mmHg | perioperative | |
Primary | Maximal tissue oxygenation | Oxygen delivery index > 550 ml/min/m2 | perioperative | |
Secondary | 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 | |
Secondary | Surgical postoperative complication | Nausea, vomiting, abdominal distension, anastomotic leakage, paralytic ileus | 7-days postoperative | |
Secondary | Anesthetic postoperative complication | Cardiogenic pulmonary edema.Cardiac index < 2.5 l/min/m2 | 24 hours postoperative | |
Secondary | Surgical postoperative complication | Wound infection and burst abdomen | 7-days postoperative | |
Secondary | Respiratory postoperative complication | Pneumonia, acute respiratory distress, postoperative ventilation and ICU admission.length of ICU stay in days. | 7-days postoperative | |
Secondary | Postoperative complication | mortality | 7-days postoperative |
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