Surgery, ColorectalPhase 4KoKrisNCT01303250
Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery
A Phase 4 study testing balanced 6% hydroxyethylstarch 130/0.4 and balanced crystalloid in people with Surgery, Colorectal, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid management will be given to optimize the stroke volume variation <= 12%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Colorectal
- What is being tested?
- balanced 6% hydroxyethylstarch 130/0.4 and balanced crystalloid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Apr 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective colorectal surgery
- minimum age 18 years
- informed consent
Who cannot join
- patients with severe cardiomyopathy or severe heart failure
- history of coagulation disorders
- intracranial hemorrhage
- patients with severe cardiovascular or respiratory disorders
- renal insufficiency
- severe liver diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balanced 6 % HES 130/0.4 vs. Balanced Crystalloid-based Infusion in Patients Undergoing Colorectal Surgery
The primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid management will be given to optimize the stroke volume variation <= 12%.
The investigators hypothesize that patients in the intervention group will need less fluid administration be optimal hemodynamic stabilized.
- Conditions
- Surgery, Colorectal
- Being tested
- balanced 6% hydroxyethylstarch 130/0.4, balanced crystalloid
- Keywords
- goal-directed fluid optimization, hemodynamic optimization, crystalloid, colloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balanced 6% hydroxyethylstarch 130/0.4Drug
Fluid administration and optimization based on cardiac output findings during surgery.
balanced crystalloidDrug
Fluid administration and optimization based on cardiac output findings during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | A balanced hydroxyethyl starch 130/0.4 will be used Receives: Drug: balanced 6% hydroxyethylstarch 130/0.4 |
| Group 2 | Active comparator | A balanced crystalloid will be used Receives: Drug: balanced crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of administered fluids
Total amount of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized
Measured: intraoperatively
Secondary outcomes (1)
Incidence of surgery related complications
Measured: day 28 and 90 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: The final decision of the review of HES-containing solution shall be awaited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery, ColorectalStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi
- Responsible party
- Sponsor
- Investigators
- Hugo Van Aken, Prof. MD, Principal investigator, Department of Anesthesia and Intensive Care, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303250
- Sponsor's protocol ID
- UKM09_0031
- Other IDs
- 2009-017595-25, 04-AnIt-09, 2009
- Acronym
- KoKris
- Status last verified
- Dec 2015
- First submitted
- 22 Feb 2011
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balanced 6 % HES 130/0.4 vs. Balanced Crystalloid-based Infusion in Patients Undergoing Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01303250
- Acronym / sponsor ID
- KoKris / UKM09_0031
- Conditions
- Surgery, Colorectal
- Keywords
- goal-directed fluid optimization, hemodynamic optimization, crystalloid, colloid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The final decision of the review of HES-containing solution shall be awaited.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- Apr 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Feb 2011 (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 primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid management will be given to optimize the stroke volume variation <= 12%.
The investigators hypothesize that patients in the intervention group will need less fluid administration be optimal hemodynamic stabilized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: balanced 6% hydroxyethylstarch 130/0.4A balanced hydroxyethyl starch 130/0.4 will be used |
| Group 2 | Active comparator | Drug: balanced crystalloidA balanced crystalloid will be used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing elective colorectal surgery
- minimum age 18 years
- informed consent
Key exclusion criteria (6 listed)
- patients with severe cardiomyopathy or severe heart failure
- history of coagulation disorders
- intracranial hemorrhage
- patients with severe cardiovascular or respiratory disorders
- renal insufficiency
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 |
|---|---|---|
| balanced 6% hydroxyethylstarch 130/0.4Fluid administration and optimization based on cardiac output findings during surgery. | Drug | Group 1 |
| balanced crystalloidFluid administration and optimization based on cardiac output findings during surgery. | Drug | Group 2 |
Primary outcome
Total amount of administered fluids
Time frame: intraoperatively
Total amount of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized
1 secondary outcome
Incidence of surgery related complications
Time frame: day 28 and 90 postoperatively
Results and safety
The study was stopped early (reason given: The final decision of the review of HES-containing solution shall be awaited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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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.
Hugo Van Aken, Prof. MD principal investigator
Department of Anesthesia and Intensive Care, University Hospital Muenster
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 balanced 6% hydroxyethylstarch 130/0.4 and balanced crystalloid in people with Surgery, Colorectal, run by University Hospital Muenster at 1 site in Germany.
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 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: stopped early, as of the sponsor's last update on 18 Dec 2015. 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 Germany. 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?
The study was stopped early (reason given: The final decision of the review of HES-containing solution shall be awaited.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of administered fluids (time frame: intraoperatively). 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 18 Dec 2015.