Colorectal CancerPhase 4FC-VENCT05726136
Fluid Challenge and Plasma Volume, During Surgery
A Phase 4 study testing acetated Ringers, albumin 5% and albumin 20% in people with Colorectal Cancer and Urologic Cancer, run by Joachim Zdolsek at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer, Urologic Cancer, Gynecologic Cancer
- What is being tested?
- acetated Ringers, albumin 5% and albumin 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 23 Oct 2023to 31 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with known cardiac failure
- <18 or >85 years
- known allergy to albumin
- extracellular hyperhydration or hypervolemia
- kidney failure
- pregnancy or planned pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Vrinnevi Hospital
Norrköping, Östergötland County, 60379
Robert Svensson, MD, +46101040000, robert.svensson@regionostergotland.se
Fredrik Schiöler, MD, +46101040000, fredrik.schioler@regionostergotland.se.se
About this study
Official title: Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
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 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.
- Conditions
- Colorectal Cancer, Urologic Cancer, Gynecologic Cancer, Colorectal Disorders, Benign Neoplasm
- Being tested
- acetated Ringers, albumin 5%, albumin 20%
- Keywords
- laparoscopic surgery, fluid therapy, plasma volume
- Medical subject headings
- Colorectal Neoplasms, Urologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetated RingersDrug
Also called Ringer's acetate, ringer acetate, acetate Ringer´s
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
Also called 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.
albumin 20%Drug
Also called Human Albumin 20%, Albumin (Human) 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.
| Study group | Role | What they receive |
|---|---|---|
| acetated Ringers | Experimental | 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. Receives: Drug: acetated Ringers |
| albumin 5% | Experimental | 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. Receives: Drug: albumin 5% |
| albumin 20% | Experimental | 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. Receives: Drug: albumin 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma volume expansion after a fluid bolus
Plasma volume using hemoglobin as an indicator of dilution
Measured: 60 minutes after an intravenous fluid bolus
Secondary outcomes (10)
Fluid Balance
Calculations of fluid balance
Measured: 18 to 24 hours
Stroke Volume
Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM))
Measured: 60 minutes after an intravenous fluid bolus
Arterial Blood Pressure
Mean Arterial Pressure, measured with an arterial line.
Measured: 60 minutes after an intravenous fluid bolus
Heart Rate
Heart rate, measured with ECG and pulseoximeter.
Measured: 60 minutes after an intravenous fluid bolus
Bioimpedance
Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments.
Measured: 18 to 24 hours
Serum Creatinin
Serum Creatinin as a measure of kidney function
Measured: 18 to 24 hours
arterial pH
Influence of a fluid bolus on arterial blood gases
Measured: 60 minutes after an intravenous fluid bolus
arterial Base Excess
Influence of a fluid bolus on arterial blood gases
Measured: 60 minutes after an intravenous fluid bolus
arterial serum sodium
Influence of a fluid bolus on Sodium concentration
Measured: 60 minutes after an intravenous fluid bolus
arterial serum chloride
Influence of a fluid bolus on Chloride concentrations
Measured: 60 minutes after an intravenous fluid bolus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start23 Oct 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 randomized parallel groups, with 20 patients in each group. Each group receives a prespecified fluid regime with: 1. acetated Ringers 2. albumin 5% or 3. albumin 20%
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joachim Zdolsek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joachim Zdolsek, University Hospital, Linkoeping
- Investigators
- Joachim Zdolsek, MD PhD, Principal investigator, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726136
- Sponsor's protocol ID
- FC-VE
- Acronym
- FC-VE
- Status last verified
- Apr 2026
- First submitted
- 15 Jan 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual de-identified results will be shared, when results are published.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
- ClinicalTrials.gov ID
- NCT05726136
- Acronym / sponsor ID
- FC-VE / FC-VE
- Conditions
- Colorectal Cancer, Urologic Cancer, Gynecologic Cancer, Colorectal Disorders, Benign Neoplasm
- Keywords
- laparoscopic surgery, fluid therapy, plasma volume
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Joachim ZdolsekUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 randomized parallel groups, with 20 patients in each group. Each group receives a prespecified fluid regime with: 1. acetated Ringers 2. albumin 5% or 3. albumin 20%
| Arm | Type | Receives |
|---|---|---|
| acetated Ringers | Experimental | Drug: acetated RingersThe 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% | Experimental | Drug: 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% | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Patients with known cardiac failure
- <18 or >85 years
- known allergy to albumin
- extracellular hyperhydration or hypervolemia
- kidney failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetated RingersAlso: Ringer's acetate, ringer acetate, acetate Ringer´sAfter 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. | Drug | acetated Ringers |
| albumin 5%Also: 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. | Drug | albumin 5% |
| albumin 20%Also: Human Albumin 20%, Albumin (Human) 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. | Drug | albumin 20% |
Primary outcome
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
10 secondary outcomes
Fluid Balance
Time frame: 18 to 24 hours
Stroke Volume
Time frame: 60 minutes after an intravenous fluid bolus
Arterial Blood Pressure
Time frame: 60 minutes after an intravenous fluid bolus
Heart Rate
Time frame: 60 minutes after an intravenous fluid bolus
Bioimpedance
Time frame: 18 to 24 hours
Serum Creatinin
Time frame: 18 to 24 hours
arterial pH
Time frame: 60 minutes after an intravenous fluid bolus
arterial Base Excess
Time frame: 60 minutes after an intravenous fluid bolus
arterial serum sodium
Time frame: 60 minutes after an intravenous fluid bolus
arterial serum chloride
Time frame: 60 minutes after an intravenous fluid bolus
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No. Individual de-identified results will be shared, when results are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joachim Zdolsek, MD PhD principal investigator
Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetated Ringers, albumin 5% and albumin 20% in people with Colorectal Cancer and Urologic Cancer, run by Joachim Zdolsek at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Svensson, MD (+4610142305, robert.svensson@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma volume expansion after a fluid bolus (time frame: 60 minutes after an intravenous fluid bolus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.