HypervolemiaNCT07192523
Effects of Different Fluid Transfusion Regimens On Glycocalyx In Patients Undergoing Thoracic Surgery.
A study testing Restrictive fluid therapy and Liberal fluid therapy in people with Hypervolemia and Hypovolemia, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypervolemia, Hypovolemia
- What is being tested?
- Restrictive fluid therapy and Liberal fluid therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2021to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Being 18-65 years old and in the American Society of Anaesthesiologists (ASA) I-III risk group.
Who cannot join
- Having heart failure
- Having a previously known vascular disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr Lutfi Kirdar City Hospital
Istanbul, Kartal, 34000
About this study
Official title: Effect of Fluid Transfusion Regimens On Glycocalyx
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).
Read the detailed description
This prospective, randomized-controlled study was conducted between August 15, 2021, and December 15, 2021, at a University Hospital. Local ethics committee approval (protocol no: 2019/514/154/10) was obtained for the study. The study was conducted in accordance with the Declaration of Helsinki. Written and verbal consent was obtained from all patients included in the study.
Participants 41 patients who underwent elective thoracic surgery were included in the study. Inclusion criteria; being 18-65 years old and in the American Society of Anaesthesiologists (ASA) I-III risk group. Exclusion criteria from the study were determined as not accepting to participate in the study, having heart failure, having a previously known vascular disease, and having more than 500 ml of blood replacement during the perioperative period.
Anesthesia protocol Patients were restricted from consuming solid and semi-solid food 6 hours before the operation. Water consumption was allowed until 2 hours before the operation. After all patients were taken to the operation room, standard monitoring techniques including electrocardiogram (ECG), pulse oximetry (SpO2), end-tidal carbon dioxide pressure (ETCO2), non-invasive blood pressure and body temperature monitoring were applied, and a Foley urinary catheter was inserted. After a 25 G intravenous (iv) catheter was opened on the back of the hand, 1-1.5 mg/kg propofol, 1-2 mcg/kg fentanyl and 0.6 mg/kg rocuronium were administered for general anesthesia induction, and tracheal intubation was performed with a No. 7.5 double lumen tracheal tube. After intubation, fresh gas flow was adjusted to 2lt/min (50% oxygen and 50% air). For maintenance of anesthesia, sevoflurane was titrated at a concentration of 2-2.5% to maintain MAC 1 and BIS 40-60. In intraoperative fluid therapy, one group (Group Restrictive (Group R)) received 3ml/kg/hr, and the other group (Group Liberal (Group L)) received 8ml/kg/hr crystalloid (Ringer Lactate). Blood replacement was applied according to the hemodynamic data and bleeding amounts of the patients. Blood samples were taken from the patients for hemogram, BUN, and creatinine measurements before and after surgery. Twenty minutes before the end of the operation, all patients were administered tramadol 100 mg and paracetamol 1 gr intravenously for postoperative analgesia. After the end of the surgery, 0.015 mg/kg atropine and 0.04 mg/kg neostigmine were administered to the patients for decurarization. Following extubation with adequate muscle strength and spontaneous ventilation, the patients were taken to the postoperative care unit.
Collection of Blood Samples 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.
Biochemical analysis Studies for the analysis of heparan sulfate and syndecan phosphate parameters were carried out in the Medical Biochemistry Laboratory of our University Faculty of Medicine. The serum concentration of Syndecan-1 was determined using the enzyme-linked immunosorbent assay (ELISA) technique. Serum syndecan-1 levels were analyzed using an ELISA kit (catalog no. E3344Hu.), purchased from BT-laboratory. Ltd. (City, China) following the manufacturer's instructions, and the results are expressed in ng/ml. The intra-assay coefficient of variation (CV) of Syndecan-1 was <8% and the inter-assay CV was <10% for this parameter.
- Conditions
- Hypervolemia, Hypovolemia
- Being tested
- Restrictive fluid therapy, Liberal fluid therapy
- Keywords
- Endothelial Dysfunction
- Medical subject headings
- Edema, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive fluid therapyOther
Also called 3 ml
Group Restrictive (Group R) received 3ml/kg/hr, crystalloid (Ringer Lactate).
Liberal fluid therapyOther
Also called 8 ml
Group Restrictive liberal received 8ml/kg/hr, crystalloid (Ringer Lactate).
| Study group | Role | What they receive |
|---|---|---|
| Effects of 3ml Fluid Transfusion Regimens On Glycocalyx | Other | In intraoperative fluid therapy, Group Restrictive received 3ml/kg/hr Ringer Lactate Receives: 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. Receives: Other: Liberal fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start15 Aug 2021
- Primary completion15 Dec 2021
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypervolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahsin Şimşek, Kocaeli Derince Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192523
- Sponsor's protocol ID
- 2019/514/154/10
- Status last verified
- Jan 2026
- First submitted
- 10 Jun 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fluid Transfusion Regimens On Glycocalyx
- ClinicalTrials.gov ID
- NCT07192523
- Acronym / sponsor ID
- 2019/514/154/10
- Conditions
- Hypervolemia, Hypovolemia
- Keywords
- Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This prospective, randomized-controlled study was conducted between August 15, 2021, and December 15, 2021, at a University Hospital. Local ethics committee approval (protocol no: 2019/514/154/10) was obtained for the study. The study was conducted in accordance with the Declaration of Helsinki. Written and verbal consent was obtained from all patients included in the study.
Participants 41 patients who underwent elective thoracic surgery were included in the study. Inclusion criteria; being 18-65 years old and in the American Society of Anaesthesiologists (ASA) I-III risk group. Exclusion criteria from the study were determined as not accepting to participate in the study, having heart failure, having a previously known vascular disease, and having more than 500 ml of blood replacement during the perioperative period.
Anesthesia protocol Patients were restricted from consuming solid and semi-solid food 6 hours before the operation. Water consumption was allowed until 2 hours before the operation. After all patients were taken to the operation room, standard monitoring techniques including electrocardiogram (ECG), pulse oximetry (SpO2), end-tidal carbon dioxide pressure (ETCO2), non-invasive blood pressure and body temperature monitoring were applied, and a Foley urinary catheter was inserted. After a 25 G intravenous (iv) catheter was opened on the back of the hand, 1-1.5 mg/kg propofol, 1-2 mcg/kg fentanyl and 0.6 mg/kg rocuronium were administered for general anesthesia induction, and tracheal intubation was performed with a No. 7.5 double lumen tracheal tube. After intubation, fresh gas flow was adjusted to 2lt/min (50% oxygen and 50% air). For maintenance of anesthesia, sevoflurane was titrated at a concentration of 2-2.5% to maintain MAC 1 and BIS 40-60. In intraoperative fluid therapy, one group (Group Restrictive (Group R)) received 3ml/kg/hr, and the other group (Group Liberal (Group L)) received 8ml/kg/hr crystalloid (Ringer Lactate). Blood replacement was applied according to the hemodynamic data and bleeding amounts of the patients. Blood samples were taken from the patients for hemogram, BUN, and creatinine measurements before and after surgery. Twenty minutes before the end of the operation, all patients were administered tramadol 100 mg and paracetamol 1 gr intravenously for postoperative analgesia. After the end of the surgery, 0.015 mg/kg atropine and 0.04 mg/kg neostigmine were administered to the patients for decurarization. Following extubation with adequate muscle strength and spontaneous ventilation, the patients were taken to the postoperative care unit.
Collection of Blood Samples 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.
Biochemical analysis Studies for the analysis of heparan sulfate and syndecan phosphate parameters were carried out in the Medical Biochemistry Laboratory of our University Faculty of Medicine. The serum concentration of Syndecan-1 was determined using the enzyme-linked immunosorbent assay (ELISA) technique. Serum syndecan-1 levels were analyzed using an ELISA kit (catalog no. E3344Hu.), purchased from BT-laboratory. Ltd. (City, China) following the manufacturer's instructions, and the results are expressed in ng/ml. The intra-assay coefficient of variation (CV) of Syndecan-1 was <8% and the inter-assay CV was <10% for this parameter.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effects of 3ml Fluid Transfusion Regimens On Glycocalyx | Other | Other: Restrictive fluid therapyIn intraoperative fluid therapy, Group Restrictive received 3ml/kg/hr Ringer Lactate |
| Effects of 8 ml Fluid Transfusion Regimens On Glycocalyx | Other | Other: Liberal fluid therapyIn intraoperative fluid therapy, one group Group Liberal received 8ml/kg/hr crystalloid Ringer Lactate. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- . Being 18-65 years old and in the American Society of Anaesthesiologists (ASA) I-III risk group.
Key exclusion criteria (2 listed)
- Having heart failure
- Having a previously known vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restrictive fluid therapyAlso: 3 mlGroup Restrictive (Group R) received 3ml/kg/hr, crystalloid (Ringer Lactate). | Other | Effects of 3ml Fluid Transfusion Regimens On Glycocalyx |
| Liberal fluid therapyAlso: 8 mlGroup Restrictive liberal received 8ml/kg/hr, crystalloid (Ringer Lactate). | Other | Effects of 8 ml Fluid Transfusion Regimens On Glycocalyx |
Primary outcome
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.
Time frame: 6 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrictive fluid therapy and Liberal fluid therapy in people with Hypervolemia and Hypovolemia, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.