Comparison of the Effects of Perioperative Liberal and Restrictive Fluid Management on the Endothelial Glycocalyx Layer in Radical Cystectomy and Urinary Diversion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fluid Retention Tissue
- Sponsor
- Istanbul University
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Hyaluronan (ng/L)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Meltem Savran Karadeniz
Associate Professor
Istanbul University
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)
Outcomes
Primary Outcomes
Hyaluronan (ng/L)
Time Frame: The blood sample will be taken at beginning and end of the surgery
Blood Hyaluronan concentration will be determined using an enzyme-linked immunosorbent
Atrial Natriuretic Peptide (ANP)( pg/mL)
Time Frame: The blood sample will be taken at beginning and end of the surgery
Blood ANP concentration will be determined using an enzyme-linked immunosorbent assay kit
Syndecan 1 (pg/mL)
Time Frame: The blood sample will be taken at beginning and end of the surgery
Blood Syndecan 1 concentration will be determined using an enzyme-linked immunosorbent
Heparan sulfate (ng/L)
Time Frame: The blood sample will be taken at beginning and end of the surgery
Blood Heparan sulfate concentration will determine using an enzyme-linked immunosorbent assay kit
Secondary Outcomes
- Hospital stay (Hour, day)(90 days postoperative)
- Thromboembolic complications(30 days postoperative)
- Cardiac complications(30 days postoperative)
- Total intensive care unit (ICU) stay (Hour, day)(30 days postoperative)
- Gastrointestinal complications(30 days postoperative)
- Amount of blood transfusion (unit)(From the beginning surgery to day 2 postoperatively)
- Surgical site complications(30 days postoperative)
- Infectious complications(30 days postoperative)
- Genitourinary complications(30 days postoperative)
- Stroke Volume Variation (SVV)(%)(From onset of the surgery up to end of the surgery, every 30 minutes)
- Systemic Vascular Resistance Index (SVRI )(dyn*s.cm-5 )(From onset of the surgery up to end of the surgery, every 30 minutes)
- Cardiac Index(CI )(l min-1 m-2),(From onset of the surgery up to end of the surgery, every 30 minutes)