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

Fluid Retention Tissue Clinical Trial

Official title:

Comparison of the Effects of Perioperative Liberal and Restrictive Fluid Management on the Endothelial Glycocalyx Layer in Radical Cystectomy and Urinary Diversion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780490
• Other study ID #: 2018/374
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: April 1, 2021

Study information

• Verified date: March 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 1, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fluid Retention Tissue

Intervention

Other:
• liberal fluid management
10 ml/ kg/ hr Ringer's lactate solution
• restrictive fluid management
2 ml/ kg/ hr Ringer's lactate solution with 2 mcg / kg / hr norepinephrine infusion

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Amount of blood transfusion (unit)	Including red cell, fresh frozen plasma	From the beginning surgery to day 2 postoperatively
Secondary	Total intensive care unit (ICU) stay (Hour, day)	Including initial ICU admission and readmission times	30 days postoperative
Secondary	Hospital stay (Hour, day)	From the beginning of surgery until actual hospital discharge	90 days postoperative
Secondary	Gastrointestinal complications	Ileus, constipation, gastrointestinal bleeding, gastric ulcer, anastomotic intestinal leakage	30 days postoperative
Secondary	Infectious complications	Urinary tract infection, pyelonephritis, urosepsis, pneumonia, wound infection	30 days postoperative
Secondary	Surgical site complications	Wound dehiscence, evisceration	30 days postoperative
Secondary	Genitourinary complications	Acute kidney injury, urethral anastamosis leak	30 days postoperative
Secondary	Cardiac complications	Acute myocardial infarction, congestive heart failure, arrhythmia	30 days postoperative
Secondary	Thromboembolic complications	pulmonary embolism	30 days postoperative
Secondary	Stroke Volume Variation (SVV)(%)	SVV will be measured with Flo-Trac system (Edward Life Sciences). Normal range is about %10-15	From onset of the surgery up to end of the surgery, every 30 minutes
Secondary	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	From onset of the surgery up to end of the surgery, every 30 minutes
Secondary	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	From onset of the surgery up to end of the surgery, every 30 minutes

External Links

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