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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
10 ml/ kg/ hr Ringer's lactate solution
2 ml/ kg/ hr Ringer's lactate solution with 2 mcg / kg / hr norepinephrine infusion
Istanbul University
Istanbul, Turkey (Türkiye)
Atrial Natriuretic Peptide (ANP)( pg/mL)
Blood ANP concentration will be determined using an enzyme-linked immunosorbent assay kit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The blood sample will be taken at beginning and end of the surgery
Amount of blood transfusion (unit)
Including red cell, fresh frozen plasma
Time frame: From the beginning surgery to day 2 postoperatively
Total intensive care unit (ICU) stay (Hour, day)
Including initial ICU admission and readmission times
Time frame: 30 days postoperative
Hospital stay (Hour, day)
From the beginning of surgery until actual hospital discharge
Time frame: 90 days postoperative
Gastrointestinal complications
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Masking
TRIPLE
Enrollment
37
Ileus, constipation, gastrointestinal bleeding, gastric ulcer, anastomotic intestinal leakage
Time frame: 30 days postoperative
Infectious complications
Urinary tract infection, pyelonephritis, urosepsis, pneumonia, wound infection
Time frame: 30 days postoperative
Surgical site complications
Wound dehiscence, evisceration
Time frame: 30 days postoperative
Genitourinary complications
Acute kidney injury, urethral anastamosis leak
Time frame: 30 days postoperative
Cardiac complications
Acute myocardial infarction, congestive heart failure, arrhythmia
Time frame: 30 days postoperative
Thromboembolic complications
pulmonary embolism
Time frame: 30 days postoperative
Stroke Volume Variation (SVV)(%)
SVV will be measured with Flo-Trac system (Edward Life Sciences). Normal range is about %10-15
Time frame: From onset of the surgery up to end of the surgery, every 30 minutes
Cardiac Index(CI )(l min-1 m-2),
CI will be measured with Flo-Trac system (Edward Life Sciences). Normal value is 2,6-4,2 l min-1 m-2
Time frame: From onset of the surgery up to end of the surgery, every 30 minutes
Systemic Vascular Resistance Index (SVRI )(dyn*s.cm-5 )
SVRI will be measured with Flo-Trac system (Edward Life Sciences). Normal value is about 900-1300 dyn\*s.cm-5
Time frame: From onset of the surgery up to end of the surgery, every 30 minutes