Breast SurgeryPhase 4NCT00431743
Fluid Infusion During Breast Surgery
A Phase 4 study testing Hydroxyethylstarch 130/0,4 and Lactated Ringer's solution in people with Breast Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The investigators want to investigate the effects of two different kinds of fluid infusions given during varicose vein surgery. Both types of fluid are regularly given during surgery, and the investigators want to compare their respective effects on balance, nausea/vomiting and orthostatic function after surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Surgery
- What is being tested?
- Hydroxyethylstarch 130/0,4 and Lactated Ringer's solution
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2009to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having performed elective breast surgery.
- Age between 18 and 70 years
- Patients who have given written consent to participate in the project after haven completely understood the contents and limitations of the protocol.
Who cannot join
- Patients who do not understand or speak Danish
- Patients who have not signed the informed consent or the written authority
- pre-medication, except 1g paracetamol
- ASA > II
- Pregnant or breastfeeding
- Known to have Renal disease
Show all 12Show fewer
- Known to have Psychiatric disorder (not considering the use of SSRI antidepressive)
- Need for crash induction or prone position.
- Oesophageal varicoses
- Necrosis or cancer in: Mouth, Pharynx, Larynx or Oesophagus
- Coarctation or aneurism in the proximal Aorta
- Severe bleeding disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
Copenhagen, Region Sjælland, 2200
Morten Bundgaard-Nielsen, M.D.
Christoffer C Jørgensen, M.S.
About this study
Official title: Phase 4 Study of Fluid Infusion During Breast Surgery.
The investigators want to investigate the effects of two different kinds of fluid infusions given during varicose vein surgery. Both types of fluid are regularly given during surgery, and the investigators want to compare their respective effects on balance, nausea/vomiting and orthostatic function after surgery.
The investigators' hypothesis is that using a colloid solution will improve orthostatic function, balance, nausea/vomiting and reduce hospital stay.
Read the detailed description
The optimal amount and type of fluid given during surgery has not been defined. It has been agreed that hypovolemia must be avoided, but at the same time it has been agreed that fluid excess is harmful for organ function.When distributing fluids it is usually either crystalloids og colloids which are given. The effects of the two types of fluid have not been compared. Our hypothesis is that using a colloid (HES 130/0,4) will improve orthostatic function, nausea/vomiting and shorten hospital stay, compared to using a crystalloid (Lactated Ringer's solution).The amount of fluid the patient receives, will be individually tailored by monitoring SV using esophageal Doppler technique during surgery.
- Conditions
- Breast Surgery
- Being tested
- Hydroxyethylstarch 130/0,4, Lactated Ringer's solution
- Keywords
- Fluid Therapy, Crystalloid, Colloid, Perioperative, Optimization, Goal-directed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyethylstarch 130/0,4Drug
Lactated Ringer's solutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate orthostatic function, measured by Finapress
Secondary outcomes (3)
To investigate the occurrence of postsurgery nausea/vomiting.
To investigate the amount of time until discharge criteria from the Postanaesthetic Care Unit have been achieved.
To investigate balance function, measured by BalanceMaster
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startApr 2009
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast SurgeryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Henrik Kehlet, M.D. Ph.d., Study director, dept of surgical patophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431743
- Sponsor's protocol ID
- Mastectomy opti.
- Status last verified
- Feb 2009
- First submitted
- 5 Feb 2007
- Last updated
- 3 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Fluid Infusion During Breast Surgery.
- ClinicalTrials.gov ID
- NCT00431743
- Acronym / sponsor ID
- Mastectomy opti.
- Conditions
- Breast Surgery
- Keywords
- Fluid Therapy, Crystalloid, Colloid, Perioperative, Optimization, Goal-directed Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 6 Feb 2007 (estimated)
- 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.
The investigators want to investigate the effects of two different kinds of fluid infusions given during varicose vein surgery. Both types of fluid are regularly given during surgery, and the investigators want to compare their respective effects on balance, nausea/vomiting and orthostatic function after surgery.
The investigators' hypothesis is that using a colloid solution will improve orthostatic function, balance, nausea/vomiting and reduce hospital stay.
Detailed description
The optimal amount and type of fluid given during surgery has not been defined. It has been agreed that hypovolemia must be avoided, but at the same time it has been agreed that fluid excess is harmful for organ function.When distributing fluids it is usually either crystalloids og colloids which are given. The effects of the two types of fluid have not been compared. Our hypothesis is that using a colloid (HES 130/0,4) will improve orthostatic function, nausea/vomiting and shorten hospital stay, compared to using a crystalloid (Lactated Ringer's solution).The amount of fluid the patient receives, will be individually tailored by monitoring SV using esophageal Doppler technique during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients having performed elective breast surgery.
- Age between 18 and 70 years
- Patients who have given written consent to participate in the project after haven completely understood the contents and limitations of the protocol.
Key exclusion criteria (12 listed)
- Patients who do not understand or speak Danish
- Patients who have not signed the informed consent or the written authority
- pre-medication, except 1g paracetamol
- ASA > II
- Pregnant or breastfeeding
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 |
|---|---|---|
| Hydroxyethylstarch 130/0,4 | Drug | – |
| Lactated Ringer's solution | Drug | – |
Primary outcome
To investigate orthostatic function, measured by Finapress
3 secondary outcomes
To investigate the occurrence of postsurgery nausea/vomiting.
To investigate the amount of time until discharge criteria from the Postanaesthetic Care Unit have been achieved.
To investigate balance function, measured by BalanceMaster
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2009.
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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. This study is not recruiting at the moment.
Henrik Kehlet, M.D. Ph.d. study director
dept of surgical patophysiology
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 Hydroxyethylstarch 130/0,4 and Lactated Ringer's solution in people with Breast Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 3 Mar 2009. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morten Bundgaard-Nielsen, M.D. (0045 35452674, morten.bundgaard-nielsen@rh.hosp.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate orthostatic function, measured by Finapress. 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 3 Mar 2009; AzTrials last refreshed its copy on 29 Oct 2026.