Vrinnevi Hospital
Norrköping, Östergötland County, 60379, Sweden
Location status: Recruiting
Location contact
Fredrik Schiöler, MD
CONTACT
Robert Svensson, MD
CONTACT
Robert Svensson, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05726136
A short bolus infusion of fluid, called "fluid challenge" is commonly recommended for fluid treatment during longer surgery. However a prolonged increase of the blood volume is a prerequisite to recommend the technique. The purpose with the study is to examine the plasma expanding effect of three different fluid challenge strategies (acetated Ringers 4 ml/kg body weight, albumin 5% 4 ml/kg body weight or albumin 20% 1 ml/kg body weight), using hemoglobin as a dilution indicator.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 4
Norrköping, Östergötland County, 60379, Sweden
Location status: Recruiting
Fredrik Schiöler, MD
CONTACT
Robert Svensson, MD
CONTACT
Robert Svensson, MD
PRINCIPAL_INVESTIGATOR
60 patients scheduled for laparoscopic abdominal surgery, with a duration exceeding 90 minutes will be included in the study. These are randomized to three different groups (20 in each groups): The first group of patients will receive boluses of acetated Ringers 4 ml/kg body weight. The second albumin 4 ml/kg body weight and the third group albumin 20% 1 ml/kg body weight.
Hemoglobin, albumin and colloid osmotic pressure (COP) is sampled the day before surgery and in the morning directly prior to the anesthesia. Bioimpedance, urine osmolality and urine-creatinin are also measured. After induction of surgery a Cardio Q probe is inserted threw the nose into the esophagus, for circulatory measurements. Initial/baseline blood samples are taken after insufflation of carbon dioxide to the abdomen. Before every bolus of fluid and 5, (10), 15, 20, 30, 40, (50) and (60) minutes new blood samples are taken for determination of hemoglobin, albumin and COP. Artery blood gases are sampled 15 minutes after every infusion or depending on the clinical need.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first fluid bolus is infused. Circulatory and volume effects are studied. If cardiac output increase a second bolus is infused and studied.
Other names: Ringer's acetate, ringer acetate, acetate Ringer´s
After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.
Other names: Albumin (Human) 5%, Human Albumin 5%
After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.
Other names: Human Albumin 20%, Albumin (Human) 20%
Time frame: 60 minutes after an intravenous fluid bolus
Plasma volume using hemoglobin as an indicator of dilution
Time frame: 18 to 24 hours
Calculations of fluid balance
Time frame: 60 minutes after an intravenous fluid bolus
Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM))
Time frame: 60 minutes after an intravenous fluid bolus
Mean Arterial Pressure, measured with an arterial line.
Time frame: 60 minutes after an intravenous fluid bolus
Heart rate, measured with ECG and pulseoximeter.
Time frame: 18 to 24 hours
Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments.
Time frame: 18 to 24 hours
Serum Creatinin as a measure of kidney function
Time frame: 60 minutes after an intravenous fluid bolus
Influence of a fluid bolus on arterial blood gases
Time frame: 60 minutes after an intravenous fluid bolus
Influence of a fluid bolus on arterial blood gases
Time frame: 60 minutes after an intravenous fluid bolus
Influence of a fluid bolus on Sodium concentration
Time frame: 60 minutes after an intravenous fluid bolus
Influence of a fluid bolus on Chloride concentrations
Contact information is provided by the study sponsor or research team.
Hans Bahlmann, MD, PhD
CONTACT
Robert Svensson, MD
CONTACT
Joachim Zdolsek
Other
Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
Acronym: FC-VE
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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