Renal Transplant SurgeryIRORNCT01485432
Goal Directed Hemodynamic Management and Renal Outcome After Renal Transplant Surgery
An observational study of Renal Transplant Surgery, run by Technical University of Munich at 1 site in Germany.
Trial summary
This study is designed to compare the incidence of delayed graft function in patients following renal transplant 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 65 years and older
- Conditions the study is for
- Renal Transplant Surgery
- What is being tested?
- PiCCO® Monitoring
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Oct 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients undergoing renal transplant surgery
Who may be able to join
- Renal Transplant Surgery
- Age ≥ 65 years
- Written informed consent
Who cannot join
- Contraindications for an arterial line in the femoral artery:
- stents
- bypasses
- severe peripheral artery occlusive disease
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 Renal Transplant Surgery?
This study is designed to compare the incidence of delayed graft function in patients following renal transplant surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.
Read the detailed description
Volume assessment and management during renal transplantation is one of the most challenging problems the anesthetist has to deal with. It seems sensible that individualized volume management and hydration therapy during the operation and during the stay at the intensive care unit could improve perfusion of the transplanted organ resulting in a better transplant function. Aim of this study is to investigate the impact of a goal directed hemodynamic management on incidence of delayed graft function (DGF) after renal transplant surgery.
Therefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management during operation and during the ICU-stay and the control group with hemodynamic management performed according to heart rate, blood pressure and central venous pressure.
- Conditions
- Renal Transplant Surgery
- Being tested
- PiCCO® Monitoring
- Keywords
- Renal transplant surgery, hemodynamic management, PiCCO, delayed graft function
- Medical subject headings
- Delayed Graft Function
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 measurements
| Study group | Role | What they receive |
|---|---|---|
| P group | Group P: Fluid Management according to measurements with PiCCO® Receives: Device: PiCCO® Monitoring | |
| C group | Group C: Conventional fluid management |
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed graft function
Measured: Start of anesthesia until day 7 after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionOct 2019
Why it stopped: Low recruitment of patients.
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 Renal Transplant 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1 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, Ismaninger Str. 22, 81675 München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485432
- Sponsor's protocol ID
- IROR
- Acronym
- IROR
- Status last verified
- Jan 2020
- First submitted
- 11 Nov 2011
- Last updated
- 14 Jan 2020
- 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 17119923Boom H, Mallat MJ, de Fijter JW, Zwinderman AH, Paul LC. Delayed graft function influences renal function, but not survival. Kidney Int. 2000 Aug;58(2):859-66. doi: 10.1046/j.1523-1755.2000.00235.x.
PubMed 10916111
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Goal Directed Hemodynamic Management Improve Renal Outcome After Renal Transplant Surgery?
- ClinicalTrials.gov ID
- NCT01485432
- Acronym / sponsor ID
- IROR / IROR
- Conditions
- Renal Transplant Surgery
- Keywords
- Renal transplant surgery, hemodynamic management, PiCCO, delayed graft function
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment of patients.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 5 Dec 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.
This study is designed to compare the incidence of delayed graft function in patients following renal transplant surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.
Detailed description
Volume assessment and management during renal transplantation is one of the most challenging problems the anesthetist has to deal with. It seems sensible that individualized volume management and hydration therapy during the operation and during the stay at the intensive care unit could improve perfusion of the transplanted organ resulting in a better transplant function. Aim of this study is to investigate the impact of a goal directed hemodynamic management on incidence of delayed graft function (DGF) after renal transplant surgery.
Therefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management during operation and during the ICU-stay and the control group with hemodynamic management performed according to heart rate, blood pressure and central venous pressure.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P group | – | Device: PiCCO® MonitoringGroup P: Fluid Management according to measurements with PiCCO® |
| C group | – | –Group C: Conventional fluid management |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing renal transplant surgery
Key inclusion criteria (3 listed)
- Renal Transplant Surgery
- Age ≥ 65 years
- Written informed consent
Key exclusion criteria (4 listed)
- Contraindications for an arterial line in the femoral artery:
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 measurements | Device | P group |
Primary outcome
delayed graft function
Time frame: Start of anesthesia until day 7 after the operation
Results and safety
The study was stopped early (reason given: Low recruitment of patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- 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.
- Background: PubMed 10916111Boom H, Mallat MJ, de Fijter JW, Zwinderman AH, Paul LC. Delayed graft function influences renal function, but not survival. Kidney Int. 2000 Aug;58(2):859-66. doi: 10.1046/j.1523-1755.2000.00235.x.
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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, Ismaninger Str. 22, 81675 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 Renal Transplant 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 3 inclusion and 4 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 14 Jan 2020. 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 was stopped early (reason given: Low recruitment of patients.). 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?
delayed graft function (time frame: Start of anesthesia until day 7 after the operation). 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 NCT01485432, 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 14 Jan 2020.