Fluid Challenge and Plasma Volume, During Surgery
Colorectal Cancer · Urologic Cancer · Gynecologic Cancer · Colorectal Disorders · Benign Neoplasm
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 4
- Age range
- 18 years - 85 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 65 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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 85 years
Exclusion Criteria:
- Patients with known cardiac failure
- \<18 or \>85 years
- known allergy to albumin
- extracellular hyperhydration or hypervolemia
- kidney failure
- pregnancy or planned pregnancy
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
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.
Drug: acetated Ringers
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.
Drug: albumin 5%
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.
Drug: albumin 20%
acetated Ringers DRUG
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% DRUG
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% DRUG
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Plasma volume expansion after a fluid bolus
Time frame: 60 minutes after an intravenous fluid bolus
Plasma volume using hemoglobin as an indicator of dilution
Secondary measures
Fluid Balance
Time frame: 18 to 24 hours
Calculations of fluid balance
Stroke Volume
Time frame: 60 minutes after an intravenous fluid bolus
Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM))
Arterial Blood Pressure
Time frame: 60 minutes after an intravenous fluid bolus
Mean Arterial Pressure, measured with an arterial line.
Heart Rate
Time frame: 60 minutes after an intravenous fluid bolus
Heart rate, measured with ECG and pulseoximeter.
Bioimpedance
Time frame: 18 to 24 hours
Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments.
Serum Creatinin
Time frame: 18 to 24 hours
Serum Creatinin as a measure of kidney function
arterial pH
Time frame: 60 minutes after an intravenous fluid bolus
Influence of a fluid bolus on arterial blood gases
arterial Base Excess
Time frame: 60 minutes after an intravenous fluid bolus
Influence of a fluid bolus on arterial blood gases
arterial serum sodium
Time frame: 60 minutes after an intravenous fluid bolus
Influence of a fluid bolus on Sodium concentration
arterial serum chloride
Time frame: 60 minutes after an intravenous fluid bolus
Influence of a fluid bolus on Chloride concentrations
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Vrinnevi HospitalNorrköping, Östergötland County, SwedenStatus unknown
Study team and timeline
- Lead sponsor
- Joachim Zdolsek
- Study start
- Oct 23, 2023 Actual
- Primary completion
- Jun 10, 2026 Actual
- Study completion
- Jun 10, 2026 Actual
- First posted
- Feb 13, 2023 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026