Major Non-cardiac SurgeryIROMNCT01035541
Goal Directed Hemodynamic Management and Renal Outcome After Major Non-cardiac Surgery
An observational study of Major Non-cardiac Surgery, run by Technical University of Munich at 1 site in Germany.
Trial summary
This study is designed to compare renal outcome of patients following major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Non-cardiac Surgery
- What is being tested?
- PiCCO® Monitoring
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Dec 2012
- Phase
- Observational
- 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
Study population: Patients udndergoing Major non-cardiac surgery
Who may be able to join
- Elective major non-cardiac surgery lasting more than 3 hours with a following intensive care unit stay for more than 3 days:
- gastrectomy
- pancreas surgery
- small bowel surgery
- esophageal surgery
- Age ≥ 18 years
- ASA classification I to III
- Written informed consent
Who cannot join
- Need for dialysis
- Contraindications for an arterial line in the femoral artery:
- stents
- bypasses
- severe peripheral artery occlusive disease
- ASA classification IV to V
- Pregnant Woman
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81675
About this study
Official title: Can Goal Directed Hemodynamic Management Improve Renal Outcome After Major Non-cardiac Surgery?
This study is designed to compare renal outcome of patients following major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.
Read the detailed description
Acute kidney injury (AKI) is a common complication after major surgery. Many studies showed that AKI is associated with different complications: higher mortality, renal replacement therapy and prolonged hospital stay resulting in higher health care costs.
Until now just a few studies are published on prevention or therapy of AKI after major surgery. Most of these investigations are underpowered or show just marginal benefit. There are no studies published investigating the impact of goal-directed hemodynamic management on renal outcome following non-cardiac major surgery, even though hemodynamic stability seems to be of paramount importance for the kidneys.
Aim of this study is to investigate the impact of a goal directed hemodynamic management on renal outcome after major non-cardiac surgery.
Therefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management and the Control group, where PICCO data will be collected but will not influence hemodynamic management. In both groups the monitoring with transpulmonary thermodilution will be continued in the intensive care unit until 72 hours after surgery.
- Conditions
- Major Non-cardiac Surgery
- Being tested
- PiCCO® Monitoring
- Keywords
- Major non-cardiac surgery,, hemodynamic management,, PiCCO,, acute kidney injury,, renal outcome
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiCCO® MonitoringDevice
Fluid and vasopressor management according to PiCCO measruements
| Study group | Role | What they receive |
|---|---|---|
| P group | Fluid Management according to measurements with PiCCO® Receives: Device: PiCCO® Monitoring | |
| C group | Conventional fluid management Receives: Device: PiCCO® Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum change in serum creatinine within 3 days
Measured: Start of anesthesia until third postoperative day (72 hours)
Secondary outcomes (1)
incidence of AKI according to the RIFLE criteria, need for dialysis, pulmonal complications, rate of anastomotic insufficiency, sepsis, reoperation
All points are additionnally registered one year after the operation via telephone-questionnaire of the patient and his general practitioner
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Non-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bettina Jungwirth, MD, Principal investigator, Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035541
- Sponsor's protocol ID
- IROM
- Acronym
- IROM
- Status last verified
- Jan 2013
- First submitted
- 17 Dec 2009
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goepfert MS, Reuter DA, Akyol D, Lamm P, Kilger E, Goetz AE. Goal-directed fluid management reduces vasopressor and catecholamine use in cardiac surgery patients. Intensive Care Med. 2007 Jan;33(1):96-103. doi: 10.1007/s00134-006-0404-2. Epub 2006 Nov 21.
PubMed 17119923Schmid S, Kapfer B, Heim M, Bogdanski R, Anetsberger A, Blobner M, Jungwirth B. Algorithm-guided goal-directed haemodynamic therapy does not improve renal function after major abdominal surgery compared to good standard clinical care: a prospective randomised trial. Crit Care. 2016 Mar 8;20:50. doi: 10.1186/s13054-016-1237-1.
PubMed 26951105
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Goal Directed Hemodynamic Management Improve Renal Outcome After Major Non-cardiac Surgery?
- ClinicalTrials.gov ID
- NCT01035541
- Acronym / sponsor ID
- IROM / IROM
- Conditions
- Major Non-cardiac Surgery
- Keywords
- Major non-cardiac surgery,, hemodynamic management,, PiCCO,, acute kidney injury,, renal outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (actual)
- First posted
- 18 Dec 2009 (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.
This study is designed to compare renal outcome of patients following major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.
Detailed description
Acute kidney injury (AKI) is a common complication after major surgery. Many studies showed that AKI is associated with different complications: higher mortality, renal replacement therapy and prolonged hospital stay resulting in higher health care costs.
Until now just a few studies are published on prevention or therapy of AKI after major surgery. Most of these investigations are underpowered or show just marginal benefit. There are no studies published investigating the impact of goal-directed hemodynamic management on renal outcome following non-cardiac major surgery, even though hemodynamic stability seems to be of paramount importance for the kidneys.
Aim of this study is to investigate the impact of a goal directed hemodynamic management on renal outcome after major non-cardiac surgery.
Therefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management and the Control group, where PICCO data will be collected but will not influence hemodynamic management. In both groups the monitoring with transpulmonary thermodilution will be continued in the intensive care unit until 72 hours after surgery.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P group | – | Device: PiCCO® MonitoringFluid Management according to measurements with PiCCO® |
| C group | – | Device: PiCCO® MonitoringConventional fluid management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients udndergoing Major non-cardiac surgery
Key inclusion criteria (8 listed)
- Elective major non-cardiac surgery lasting more than 3 hours with a following intensive care unit stay for more than 3 days:
- Age ≥ 18 years
- ASA classification I to III
- Written informed consent
Key exclusion criteria (7 listed)
- Need for dialysis
- Contraindications for an arterial line in the femoral artery:
- ASA classification IV to V
- Pregnant Woman
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 |
|---|---|---|
| PiCCO® MonitoringFluid and vasopressor management according to PiCCO measruements | Device | C group, P group |
Primary outcome
maximum change in serum creatinine within 3 days
Time frame: Start of anesthesia until third postoperative day (72 hours)
1 secondary outcome
incidence of AKI according to the RIFLE criteria, need for dialysis, pulmonal complications, rate of anastomotic insufficiency, sepsis, reoperation
Time frame: 1 year
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 17 Jan 2013.
- Background: PubMed 17119923Goepfert MS, Reuter DA, Akyol D, Lamm P, Kilger E, Goetz AE. Goal-directed fluid management reduces vasopressor and catecholamine use in cardiac surgery patients. Intensive Care Med. 2007 Jan;33(1):96-103. doi: 10.1007/s00134-006-0404-2. Epub 2006 Nov 21.
- Derived from this study: PubMed 26951105Schmid S, Kapfer B, Heim M, Bogdanski R, Anetsberger A, Blobner M, Jungwirth B. Algorithm-guided goal-directed haemodynamic therapy does not improve renal function after major abdominal surgery compared to good standard clinical care: a prospective randomised trial. Crit Care. 2016 Mar 8;20:50. doi: 10.1186/s13054-016-1237-1.
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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.
Bettina Jungwirth, MD principal investigator
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Non-cardiac Surgery, run by Technical University of Munich 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 8 inclusion and 7 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 17 Jan 2013. 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.
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?
maximum change in serum creatinine within 3 days (time frame: Start of anesthesia until third postoperative day (72 hours)). 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 NCT01035541, which also lists 2 linked publications.
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 17 Jan 2013.