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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05726136
Other study ID # FC-VE
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 23, 2023
Est. completion date October 31, 2025

Study information

Verified date March 2024
Source University Hospital, Linkoeping
Contact Robert Svensson, MD
Phone +4610142305
Email robert.svensson@regionostergotland.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Written consent to participate in the study - For women: relevant contraceptive, menopausal or a negative pregnancy test. - ASA category I to III - Laparoscopic abdominal surgery, with a duration of at least 90 minutes. - 18 to 80 years Exclusion Criteria: - Patients with known cardiac failure - <18 or >80 years - known allergy to albumin - extracellular hyperhydration or hypervolemia - kidney failure - pregnancy or planned pregnancy

Study Design


Intervention

Drug:
acetated Ringers
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.
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.
albumin 20%
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.

Locations

Country Name City State
Sweden Vrinnevi Hospital Norrköping Östergötland

Sponsors (1)

Lead Sponsor Collaborator
Joachim Zdolsek

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma volume expansion after a fluid bolus Plasma volume using hemoglobin as an indicator of dilution 60 minutes after an intravenous fluid bolus
Secondary Fluid Balance Calculations of fluid balance 18 to 24 hours
Secondary Stroke Volume Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM)) 60 minutes after an intravenous fluid bolus
Secondary Arterial Blood Pressure Mean Arterial Pressure, measured with an arterial line. 60 minutes after an intravenous fluid bolus
Secondary Heart Rate Heart rate, measured with ECG and pulseoximeter. 60 minutes after an intravenous fluid bolus
Secondary Bioimpedance Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments. 18 to 24 hours
Secondary Serum Creatinin Serum Creatinin as a measure of kidney function 18 to 24 hours
Secondary arterial pH Influence of a fluid bolus on arterial blood gases 60 minutes after an intravenous fluid bolus
Secondary arterial Base Excess Influence of a fluid bolus on arterial blood gases 60 minutes after an intravenous fluid bolus
Secondary arterial serum sodium Influence of a fluid bolus on Sodium concentration 60 minutes after an intravenous fluid bolus
Secondary arterial serum chloride Influence of a fluid bolus on Chloride concentrations 60 minutes after an intravenous fluid bolus
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