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Completed

NCT Number: NCT04780490

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

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.

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Key information

Conditions

Fluid Retention Tissue Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

liberal fluid management

Other

10 ml/ kg/ hr Ringer's lactate solution

restrictive fluid management

Other

2 ml/ kg/ hr Ringer's lactate solution with 2 mcg / kg / hr norepinephrine infusion

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Amount of blood transfusion (unit)

    Time frame: From the beginning surgery to day 2 postoperatively

    Including red cell, fresh frozen plasma

  2. Total intensive care unit (ICU) stay (Hour, day)

    Time frame: 30 days postoperative

    Including initial ICU admission and readmission times

  3. Hospital stay (Hour, day)

    Time frame: 90 days postoperative

    From the beginning of surgery until actual hospital discharge

  4. Gastrointestinal complications

    Time frame: 30 days postoperative

    Ileus, constipation, gastrointestinal bleeding, gastric ulcer, anastomotic intestinal leakage

  5. Infectious complications

    Time frame: 30 days postoperative

    Urinary tract infection, pyelonephritis, urosepsis, pneumonia, wound infection

  6. Surgical site complications

    Time frame: 30 days postoperative

    Wound dehiscence, evisceration

  7. Genitourinary complications

    Time frame: 30 days postoperative

    Acute kidney injury, urethral anastamosis leak

  8. Cardiac complications

    Time frame: 30 days postoperative

    Acute myocardial infarction, congestive heart failure, arrhythmia

  9. Thromboembolic complications

    Time frame: 30 days postoperative

    pulmonary embolism

  10. Stroke Volume Variation (SVV)(%)

    Time frame: 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

  11. Cardiac Index(CI )(l min-1 m-2),

    Time frame: 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

  12. Systemic Vascular Resistance Index (SVRI )(dyn*s.cm-5 )

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2021
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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