Fluid Challenge and Plasma Volume, During Surgery

Phase 4

Recruiting

• Conditions: Colorectal Cancer; Urologic Cancer; Gynecologic Cancer; Colorectal Disorders; Benign Neoplasm
• Interventions: Drug: acetated Ringers; Drug: albumin 5%; Drug: albumin 20%

• Registration Number: NCT05726136
• Lead Sponsor: Joachim Zdolsek

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-01-15
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-13
• Study Start: 2023-10-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acetated Ringers	acetated Ringers	The circulatory effect of a bolus infusion with 4 ml/kg body weight of acetated Ringers will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied.
albumin 5%	albumin 5%	The circulatory effect of a bolus infusion with 4 ml/kg body weight of Albumin 5% will be studied. If cardiac output increases with 10% a second bolus will be infused and further studied.
albumin 20%	albumin 20%	The circulatory effect of a bolus infusion with 1 ml/kg body weight of Albumin 20% will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied.

Primary Outcome Measures

Name	Time	Method
Plasma volume expansion after a fluid bolus	60 minutes after an intravenous fluid bolus	Plasma volume using hemoglobin as an indicator of dilution

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vrinnevi Hospital; 🇸🇪 Norrköping, Östergötland, Sweden