Major Abdominal SurgeryPhase 4REPEATNCT00549419
Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Abdominal Surgery
A Phase 4 study testing Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine and Goal-directed hemodynamic therapy in people with Major Abdominal Surgery, run by Klinikum Ludwigshafen at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether the early identification and more precise intervention of goal-directed intraoperative plasma volume expansion and catecholamine therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal vital signs will improve postoperative organ… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine and Goal-directed hemodynamic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is scheduled for elective major abdominal surgery and has two or more risk factors according to the Lee classification scheme.
- Patient can sign informed consent before surgery.
- Patient is able to comply with the study procedure.
- Patient must require an indwelling radial or a femoral artery catheter.
- Patient must be 20 years old or older.
- Patient must be 40kg or heavier.
- Patients height and weight can be accurately obtained prior to study start.
Who cannot join
- Emergency surgery.
- Patients with aortic or mitral valve regurgitation.
- Renal insufficiency requiring hemodialysis.
- Liver dysfunction (alanine/aspartate aminotransferase >40 U/L).
- Patient with contraindications for the placement of radial, femoral or other arterial cannulae.
- Patient being treated with an intraaortic balloon pump.
- Female patients with a known pregnancy.
- Patient is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Patients Undergoing Major Abdominal Surgery
The purpose of this study is to determine whether the early identification and more precise intervention of goal-directed intraoperative plasma volume expansion and catecholamine therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal vital signs will improve postoperative organ function, in particular renal function, in patients undergoing major abdominal surgery.
- Conditions
- Major Abdominal Surgery
- Being tested
- Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine, Goal-directed hemodynamic therapy, Standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamineDrug
The Control group will be assessed using the standard care of traditional vital signs
Goal-directed hemodynamic therapyDrug
Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
Standard of careDrug
Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | In the Treatment group, the traditional vital signs and APCO are made continuously available for fluid and catecholamine optimization and clinical decision making. Receives: Drug: Goal-directed hemodynamic therapy |
| 2 | Active comparator | Not described Receives: Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine; Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate.
Measured: 6 month
Secondary outcomes (1)
Total fluid requirements (type and volume); Drug requirement (type and volume); Other organ function (myocardial function, liver function, endothelial function, degree of inflammation)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Abdominal SurgeryStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Ludwigshafen
- Sponsor type
- University, hospital or other
- Investigators
- Stefan W. Suttner, M.D. Ph.D., Study director, Klinikum Ludwigshafen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549419
- Sponsor's protocol ID
- 2007-06
- Acronym
- REPEAT
- Status last verified
- Jan 2009
- First submitted
- 23 Oct 2007
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mayer J, Boldt J, Mengistu AM, Rohm KD, Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010;14(1):R18. doi: 10.1186/cc8875. Epub 2010 Feb 15.
PubMed 20156348
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00549419
- Acronym / sponsor ID
- REPEAT / 2007-06
- Conditions
- Major Abdominal Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Klinikum LudwigshafenUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Oct 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 purpose of this study is to determine whether the early identification and more precise intervention of goal-directed intraoperative plasma volume expansion and catecholamine therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal vital signs will improve postoperative organ function, in particular renal function, in patients undergoing major abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Goal-directed hemodynamic therapyIn the Treatment group, the traditional vital signs and APCO are made continuously available for fluid and catecholamine optimization and clinical decision making. |
| 2 | Active comparator | Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine, Drug: Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is scheduled for elective major abdominal surgery and has two or more risk factors according to the Lee classification scheme.
- Patient can sign informed consent before surgery.
- Patient is able to comply with the study procedure.
- Patient must require an indwelling radial or a femoral artery catheter.
- Patient must be 20 years old or older.
Key exclusion criteria (8 listed)
- Emergency surgery.
- Patients with aortic or mitral valve regurgitation.
- Renal insufficiency requiring hemodialysis.
- Liver dysfunction (alanine/aspartate aminotransferase >40 U/L).
- Patient with contraindications for the placement of radial, femoral or other arterial cannulae.
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 |
|---|---|---|
| Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamineThe Control group will be assessed using the standard care of traditional vital signs | Drug | 2 |
| Goal-directed hemodynamic therapyRingers lactate, hydroxyethyl starch; norepinephrine, dobutamine | Drug | 1 |
| Standard of careRingers lactate, hydroxyethyl starch; norepinephrine, dobutamine | Drug | 2 |
Primary outcome
The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate.
Time frame: 6 month
1 secondary outcome
Total fluid requirements (type and volume); Drug requirement (type and volume); Other organ function (myocardial function, liver function, endothelial function, degree of inflammation)
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
- Derived from this study: PubMed 20156348Mayer J, Boldt J, Mengistu AM, Rohm KD, Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010;14(1):R18. doi: 10.1186/cc8875. Epub 2010 Feb 15.
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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.
Stefan W. Suttner, M.D. Ph.D. study director
Klinikum Ludwigshafen
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 Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine and Goal-directed hemodynamic therapy in people with Major Abdominal Surgery, run by Klinikum Ludwigshafen 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 23 Dec 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate. (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00549419, which also lists 1 linked publication.
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 23 Dec 2009.