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The effect of different doses of infusion solutions on the endothelial glycocalyx layer in patients who underwent laparoscopic cholecystectomy

The effect of different doses of infusion solutions on the endothelial glycocalyx layer in patients who underwent laparoscopic cholecystectomy - The effect of various doses of crystalloids on haemodynamics, safety, cost-effectiveness and endothelial glycocalyx layer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00007904
Enrollment
60
Registered
2015-04-15
Start date
2015-03-30
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influence of three doses of infusion solutions, restricitive vs. two liberal doses, on endothelial glycocalyx and on atrial natriuretic pepitde secretion according to various volume of infusions and the infulence of three different doses of infusions on global haemodynamics during surgery. The secondary objective is to track function changes of individual organs and organ systems (kidney, liver electrolyte and acid base status, haematological parameters, lactates) in each group. The objective

Interventions

Group 1: Two groups of patients received a greater amount of crystalloids (Ringer's solution), manufactured by B. Braun Melsungen AG, 34209 Melsungen, Germany. This groups were Liberal 1 group which r

Sponsors

Karlovac General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with anesthesiologic risk I and II according to American Society of Anesthesiologists (ASA). ASA I status includes completely healthy patients and ASA II status includes patients with well regulated chronic dsseases such as arterial hypertension. Patients between 18 and 75 years old, male or female.

Exclusion criteria

Exclusion criteria: The patients younger than 18 and older than 75 years of age will be excluded and those with a local or systemic inflammatory and immune disease, diabetes, COPD, acute heart failure, acute and chronic renal failure, hematologic and malignant diseases, atherosclerotic disease, stroke and subarachnoid haemorrhageliver damage and patients that will receive blood products during surgery as well as patients who will develop acute renal failure during surgery or will become hypotensive with organ hypoperfusion and ischemia.

Design outcomes

Primary

MeasureTime frame
The primary objective of this study was to examine the effects of various volumes of infusion solutions on patients’ concentrations of syndecan-1, heparan sulfate, and hyaluronic acid, the main components of the endothelial glycocalyx, in patients undergoing laparoscopic cholecystectomy. We also measured patients’ concentrations of ANP and how they correlated with changes in the main glycocalyx components. The study included subjects (patients) with gallstones who underwent surgical procedure of laparoscopic cholecystectomy. Laboratory samples were taken preoperative, during operation (after the establishment of pneumoperitoneum), immediately after the operation and 6 h after the operation.

Secondary

MeasureTime frame
The secondary objective was to track correlations of changes in function of individual organs such as kidney (urea, creatinine, sodium, potassium), acid base status, lactates (hypoperfusion marker), tissue perfusion (central venous oxygen saturation) and measuring of C reactive protein and albumines with endothelial glycocalyx damage as well haemodynamic changes. Laboratory samples were taken preoperative, during operation (after the establishment of pneumoperitoneum), immediately after the operation and 6 h after the operation. The secondary objective of the current study was also to determine the effectiveness and safety of a restrictive regimen of crystalloids during laparoscopic cholecystectomy, according to hemodynamic parameters, arterial blood gas (ABG), lactate concentrations, critical outcomes (respiratory and cardiac complications, renal failure), early postoperative surgical complications, length of hospital stay, 1-year morbidity, and mortality and to determine the cost-effectiveness of various volumes of crystalloids.

Countries

Croatia

Contacts

Public ContactMatija Belavic

Department of Anesthesiology, Reanimatology and Intensive Care, Karlovac General Hospital

mbelavic1@gmail.com+38598548570

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026