Clinical trial NCT04780490: Comparison of Liberal and Restrictive Fluid Management on the Endothelial Glycocalyx in Radical Cystectomy
Official title: Comparison of the Effects of Perioperative Liberal and Restrictive Fluid Management on the Endothelial Glycocalyx Layer in Radical Cystectomy and Urinary Diversion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Retention Tissue
Keywords: peroperative fluid management
restrictive fluid therapy
endothelial glycocalyx
Liberal fluid therapy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: There is no strong evidence about the optimal fluid resuscitation for the patients undergoing major surgeries. Avoiding excess fluid resuscitation in the perioperative period is essential for reducing postoperative complications, morbidity and long-term mortality. In the perioperative period, ANP is released with increased wall stress in the cardiac atrium due to excess fluid loading. With the release of ANP, damage occurs in the glycocalyx layer, which is the structure primarily responsible for the permeability in the vascular endothelium.

Thus, the amount of ANP released from atrium and heparan sulfate, syndecan 1, hyaluronan in the glycocalyx layer structure increases in the blood.

The aim of this study is 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. The blood samples will be taken at the beginning and at the end of the surgery.

The primary outcome of this study is the increase in ANP levels and heparan sulfate , hyaluronic acid, syndecan 1 levels which are the glycocalyx damage products in blood.

Secondary outcomes are intraoperative advanced hemodynamic cardiac measurement values, the amount of blood and blood products replaced to patients, duration of intensive care stay, duration of hospital stay, cardiac and respiratory complications, gastrointestinal complications, urinary complications, surgical complications such as anastomotic leaks, wound infection and fistula.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Atrial Natriuretic Peptide (ANP)( pg/mL)
timeFrame: The blood sample will be taken at beginning and end of the surgery
measure: Heparan sulfate (ng/L)
timeFrame: The blood sample will be taken at beginning and end of the surgery
measure: Syndecan 1 (pg/mL)
timeFrame: The blood sample will be taken at beginning and end of the surgery
measure: Hyaluronan (ng/L)
timeFrame: The blood sample will be taken at beginning and end of the surgery
Secondary outcomes:
measure: Amount of blood transfusion (unit)
timeFrame: From the beginning surgery to day 2 postoperatively
measure: Total intensive care unit (ICU) stay (Hour, day)
timeFrame: 30 days postoperative
measure: Hospital stay (Hour, day)
timeFrame: 90 days postoperative
measure: Gastrointestinal complications
timeFrame: 30 days postoperative
measure: Infectious complications
timeFrame: 30 days postoperative
measure: Surgical site complications
timeFrame: 30 days postoperative
measure: Genitourinary complications
timeFrame: 30 days postoperative
measure: Cardiac complications
timeFrame: 30 days postoperative
measure: Thromboembolic complications
timeFrame: 30 days postoperative
measure: Stroke Volume Variation (SVV)(%)
timeFrame: From onset of the surgery up to end of the surgery, every 30 minutes
measure: Cardiac Index(CI )(l min-1 m-2),
timeFrame: From onset of the surgery up to end of the surgery, every 30 minutes
measure: Systemic Vascular Resistance Index (SVRI )(dyn*s.cm-5 )
timeFrame: From onset of the surgery up to end of the surgery, every 30 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University
name: Meltem Savran KARADENİZ
role: PRINCIPAL_INVESTIGATOR
References: