NCT07192523

Brief Summary

Introduction: Endothelial Glycocalyx (EG) composing of proteoglycans heparan sulfate (HS), syndecan, and plasma proteins forms a physiologically active surface layer on the vascular endothelium, regulates oncotic pressure. We aimed to compare the effects of two different fluid transfusion regimens on EG. Materials and Methods: 41 patients with ASA I-III physical status were included in this prospective, randomized controlled study. We collected blood samples before anesthesia induction and after surgery to measure hemoglobin-hematocrit levels and biochemical parameters. Hemodynamic parameters were recorded every 15 minutes perioperatively. We divided the patients into two groups: Group R received 3 ml/kg/h, and Group L received 8 ml/kg/h of Ringer's lactate infusion. To assess endothelial damage, HS and syndecan levels, blood samples were taken after anesthesia induction(T1), after pneumonectomy or lobectomy(T2), and at the end of surgery(T3).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
Last Updated

January 5, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

June 10, 2025

Last Update Submit

January 1, 2026

Conditions

Keywords

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Our primary aim in the study was to evaluate the changes in HS and syndecan 1 levels after 8 ml/kg/hr or 3 ml/kg/hr fluid transfusion in thoracic surgery.

    To evaluate endothelial damage, blood samples were taken from patients in both groups 3 times. The time of taking the samples was determined as; the blood sample taken after the placement of the IV cannula (T1), the blood sample taken after pneumonectomy or lobectomy (T2), and the blood sample taken after the patient was extubated following the end of surgery (T3). Venous blood samples were placed in a 5 ml vacuum tube with a serum separator. The samples were centrifuged at 1500 g for 10 minutes to separate the serum, and these samples were stored at -80 °C.

    6 month

Study Arms (2)

Effects of 3ml Fluid Transfusion Regimens On Glycocalyx

OTHER

In intraoperative fluid therapy, Group Restrictive received 3ml/kg/hr Ringer Lactate

Other: Restrictive fluid therapy

Effects of 8 ml Fluid Transfusion Regimens On Glycocalyx

OTHER

In intraoperative fluid therapy, one group Group Liberal received 8ml/kg/hr crystalloid Ringer Lactate.

Other: Liberal fluid therapy

Interventions

Group Restrictive (Group R) received 3ml/kg/hr, crystalloid (Ringer Lactate).

Also known as: 3 ml
Effects of 3ml Fluid Transfusion Regimens On Glycocalyx

Group Restrictive liberal received 8ml/kg/hr, crystalloid (Ringer Lactate).

Also known as: 8 ml
Effects of 8 ml Fluid Transfusion Regimens On Glycocalyx

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18-65 years old and in the American Society of Anaesthesiologists (ASA) I-III risk group.

You may not qualify if:

  • Having heart failure
  • Having a previously known vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr Lutfi Kirdar City Hospital

Istanbul, Kartal, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

EdemaHypovolemia

Interventions

N-(2-aminophenyl)-6-(4-(2-(3,5-dihydroxycyclohexylidene)ethylidene)-7a-methyloctahydro-1H-inden-1-yl)-4-methylhepta-2,4-dienamide

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCİATED PROFESSOR

Study Record Dates

First Submitted

June 10, 2025

First Posted

September 25, 2025

Study Start

August 15, 2021

Primary Completion

December 15, 2021

Study Completion

August 30, 2025

Last Updated

January 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations