Comparison of Liberal and Restrictive Fluid Management on the Endothelial Glycocalyx in Radical Cystectomy

NCT04780490 | Completed

• 1 other identifier: 2018/374
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effect of the liberal and restrictive fluid treatments which are routinely performed in major urological surgeries in the perioperative period on ANP release and the endothelial glycocalyx layer. In the study, the investigators aimed to compare changes in the glycocalyx structure by measuring the blood levels of ANP and heparan sulfate, hyaluronan and syndecan 1, which form the glycocalyx structure on the patients who received the liberal and restrictive fluid treatments during major urological surgeries.

Conditions

Fluid Retention Tissue

Keywords

peroperative fluid management; restrictive fluid therapy; endothelial glycocalyx; Liberal fluid therapy

Outcome Measures

Primary Outcomes (4)

• Atrial Natriuretic Peptide (ANP)( pg/mL)

  Blood ANP concentration will be determined using an enzyme-linked immunosorbent assay kit

  The blood sample will be taken at beginning and end of the surgery

• Heparan sulfate (ng/L)

  Blood Heparan sulfate concentration will determine using an enzyme-linked immunosorbent assay kit

  The blood sample will be taken at beginning and end of the surgery

• Syndecan 1 (pg/mL)

  Blood Syndecan 1 concentration will be determined using an enzyme-linked immunosorbent

  The blood sample will be taken at beginning and end of the surgery

• Hyaluronan (ng/L)

  Blood Hyaluronan concentration will be determined using an enzyme-linked immunosorbent

  The blood sample will be taken at beginning and end of the surgery

Secondary Outcomes (12)

• Amount of blood transfusion (unit)

  From the beginning surgery to day 2 postoperatively

• Total intensive care unit (ICU) stay (Hour, day)

  30 days postoperative

• Hospital stay (Hour, day)

  90 days postoperative

• Gastrointestinal complications

  30 days postoperative

• Infectious complications

  30 days postoperative

Study Arms (2)

liberal fluid therapy

ACTIVE COMPARATOR

Patients will be applied 2 mg midazolam for premedication. Before anesthesia induction, epidural catheter will be inserted to all patients and test dose will be made with 3 cc % 2 lidocaine (No medication from the epidural catheter will be administered during surgery). Standard anesthesia induction will be applied (fentanyl 2 mcg/kg; propofol 2 mg/kg; rocuronium 0.6 mg/kg ), and after intubation maintenance of anesthesia will be achieved with sevoflurane with a minimum alveolar concentration (MAC) of 0.8-1. Fluid resuscitation will be started with 10 ml / kg / hr Ringer's lactate solution. In patients with MAP \<65 mmHg, 250 ml of Ringer's lactate solution will be given as a bolus. If the hypotension persists, the bolus 250 ml Ringer's lactate solution will be repeated up to 10 times.

Other: liberal fluid management

restrictive fluid therapy

ACTIVE COMPARATOR

Patients will be applied 2 mg midazolam for premedication. Before anesthesia induction, epidural catheter will be inserted to all patients and test dose will be made with 3 cc % 2 lidocaine ( No medication from the epidural catheter will be administered during surgery. ) Standard anesthesia induction will be applied ( fentanyl 2 mcg/kg; propofol 2 mg/kg; rocuronium 0.6 mg/kg ) and after intubation maintenance of anesthesia will be achieved with sevoflurane with a minimum alveolar concentration (MAC) of 0.8-1. Fluid resuscitation will be started with 2 ml / kg / hr Ringer's lactate solution and norepinephrine infusion at a dose of 2 mcg / kg / hr. In patients with MAP\<65 mmHg, norepinephrine dose will be increased up to 8 mcg / kg / hr. If the hypotension persists although the norepinephrine dose is 8 mcg / kg / hr, 250 ml bolus Ringer's lactate solution will be given.

Other: restrictive fluid management

Interventions

liberal fluid management OTHER

10 ml/ kg/ hr Ringer's lactate solution

liberal fluid therapy

restrictive fluid management OTHER

2 ml/ kg/ hr Ringer's lactate solution with 2 mcg / kg / hr norepinephrine infusion

restrictive fluid therapy

Eligibility Criteria

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

You may qualify if:

• ASA (The American Society of Anesthesiologists) status I-II-III patients
• Cases undergoing major urological surgery
• Cases for invasive artery monitoring and central venous catheterization
• Patients receiving general anesthesia
• Volunteering to participate in the study

You may not qualify if:

• Coagulopathy
• Patients with severe heart, kidney and liver dysfunction (EF \<35% and / or GFR \<30, Cre:\> 2.5 and / or impaired liver function tests)

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

Location

Related Links

• Restrictive deferred hydration combined with preemptive norepinephrine infusion during radical cystectomy reduces postoperative complications and hospitalization time: a randomized clinical trial.
• Hypervolemia increases release of atrial natriuretic peptide and shedding of the endothelial glycocalyx.
• Revised Starling equation and the glycocalyx model of transvascular fluid exchange: an improved paradigm for prescribing intravenous fluid therapy

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Meltem Savran KARADENİZ

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: March 3, 2021
• Study Start: March 1, 2018
• Primary Completion: March 15, 2021
• Study Completion: April 1, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

TU (1)