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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00007904
• Date of registration: 15/04/2015
• Prospective Registration: No
• Primary sponsor: Karlovac General Hospital
• Public title: The effect of different doses of infusion solutions on the endothelial glycocalyx layer in patients who underwent laparoscopic cholecystectomy
• Scientific title: 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
• Date of first enrolment: 30/03/2015
• Target sample size: 60
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00007904
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: parallel; Study design purpose: treatment
• Phase: 4

Countries of recruitment

Croatia

Contacts

• Name: Matija Belavic
• Affiliation: Department of Anesthesiology, Reanimatology and Intensive Care, Karlovac General Hospital

• Name: Matija Belavic
• Affiliation: Department of Anesthesiology, Reanimatology and Intensive Care, Karlovac General Hospital

Key inclusion & exclusion 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: 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.

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

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 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. The second objective was to determine the cost-effectiveness of various volumes of crystalloids.

Intervention(s)

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 received 5 ml / kg / hr intraoperatively and six hours postoperatively and Liberal 2 group which received 15 ml/kg/hr intraoperatively and 10 ml/kg/hr six hours postoperatively.
Laboratory samples were taken preoperative, during operation (after the establishment of pneumoperitoneum), immediately after the end of surgery and 6 h after the operation.
Group 2: The other group will receive a smaller amount of crystalloids (Ringer's solution), manufactured by B. Braun Melsungen AG, 34209 Melsungen, Germany. This group is restriction group with ammount of infusions 1 ml / kg / h. Laboratory samples were taken preoperative, during operation (after the establishment of pneumoperitoneum), immediately after the end of surgery and 6 h after the operation.

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

U1111-1168-7830

Source(s) of Monetary Support

Karlovac General Hospital

Ethics review

Status: Approved
Approval date: 16/03/2015
Contact:

Results

• Date Completed: 14/11/2017
• URL: http://drks.de/search/en/trial/DRKS00007904#studyResults