Fluid Retention Tissue
Conditions
Keywords
peroperative fluid management, restrictive fluid therapy, endothelial glycocalyx, Liberal fluid therapy
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.
Interventions
OTHERliberal fluid management
10 ml/ kg/ hr Ringer's lactate solution
2 ml/ kg/ hr Ringer's lactate solution with 2 mcg / kg / hr norepinephrine infusion
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hyaluronan (ng/L) | The blood sample will be taken at beginning and end of the surgery | Blood Hyaluronan concentration will be determined using an enzyme-linked immunosorbent |
| Syndecan 1 (pg/mL) | 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 |
| Atrial Natriuretic Peptide (ANP)( pg/mL) | 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 |
| Heparan sulfate (ng/L) | 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
| Measure | Time frame | Description |
|---|---|---|
| Infectious complications | 30 days postoperative | Urinary tract infection, pyelonephritis, urosepsis, pneumonia, wound infection |
| Surgical site complications | 30 days postoperative | Wound dehiscence, evisceration |
| Genitourinary complications | 30 days postoperative | Acute kidney injury, urethral anastamosis leak |
| Cardiac complications | 30 days postoperative | Acute myocardial infarction, congestive heart failure, arrhythmia |
| Amount of blood transfusion (unit) | From the beginning surgery to day 2 postoperatively | Including red cell, fresh frozen plasma |
| Stroke Volume Variation (SVV)(%) | From onset of the surgery up to end of the surgery, every 30 minutes | SVV will be measured with Flo-Trac system (Edward Life Sciences). Normal range is about %10-15 |
| Cardiac Index(CI )(l min-1 m-2), | From onset of the surgery up to end of the surgery, every 30 minutes | CI will be measured with Flo-Trac system (Edward Life Sciences). Normal value is 2,6-4,2 l min-1 m-2 |
| Systemic Vascular Resistance Index (SVRI )(dyn*s.cm-5 ) | From onset of the surgery up to end of the surgery, every 30 minutes | SVRI will be measured with Flo-Trac system (Edward Life Sciences). Normal value is about 900-1300 dyn\*s.cm-5 |
| Thromboembolic complications | 30 days postoperative | pulmonary embolism |
| Total intensive care unit (ICU) stay (Hour, day) | 30 days postoperative | Including initial ICU admission and readmission times |
| Hospital stay (Hour, day) | 90 days postoperative | From the beginning of surgery until actual hospital discharge |
| Gastrointestinal complications | 30 days postoperative | Ileus, constipation, gastrointestinal bleeding, gastric ulcer, anastomotic intestinal leakage |
Countries
Turkey (Türkiye)
Outcome results
None listed