IschemiaKISMEDNCT01915446
Kidney and Intestinal Markers for Early Detection of Organ Injury After Endovascular Aortic Repair
An observational study of Ischemia and Fatty Acid-Binding Proteins, run by University Hospital Regensburg at 1 site in Germany.
Trial summary
This study aims to investigate the predictive value of novel biomarkers and contrast-enhanced ultrasonography for early detection of abdominal end-organ (kidney and intestinum) hypoperfusion and ischemia in patients undergoing endovascular aortic repair (EVAR) for aortic aneurysm or dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia, Fatty Acid-Binding Proteins, Mesenteric Vascular Disease
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Nov 2014
- 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 undergoing endovascular aortic repair in a University hospital
Who may be able to join
- Existence of an aortic aneurysm with need of repair as indicated by the treating vascular surgeon
- Aortic stenting involving the origin of both mesenteric (i.e. superior and inferior mesenteric arteries) and kidney arteries
- Central line is present to perform repeated blood collections
- Written informed consent is obtained.
Who cannot join
- Pre-existing severe liver or kidney injury (defined as spontaneous international normalized ratio (INR) >2 or creatinine >2 mg/dl or renal-replacement therapy in the pre-operative course.)
- Known allergy to ultrasound contrast media (exclusion for the CEUS but not for marker evaluation)
- Anemia with hemoglobin concentration < 7g/dl
- Patients < 18 years of age
- Patients not able to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kidney and Intestinal Markers for Early Detection of Organ Injury After Endovascular Aortic Repair - The KISMED Study
This study aims to investigate the predictive value of novel biomarkers and contrast-enhanced ultrasonography for early detection of abdominal end-organ (kidney and intestinum) hypoperfusion and ischemia in patients undergoing endovascular aortic repair (EVAR) for aortic aneurysm or dissection. In this context, patients will be monitored for renal biomarkers (TIMP-2, IGFBP7) and intestinal biomarkers (plasmatic intestinal fatty acid binding protein (i-FABP)) and local tissue perfusion will be assessed using contrast-enhanced ultrasonography (CEUS).
The ultimate goal of this study is an early identification of patients developing one or both of these complications, which may facilitate a timely intervention to improve outcome.
- Keywords
- EVAR, endovascular aortic repair, acute kidney failure, mesenteric ischemia
- Medical subject headings
- Ischemia, Acute Kidney Injury, Mesenteric Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of biomarkers of abdominal organ injury (plasmatic i-FABP, TIMP-2, IGFBP7)
The primary objective of this study is to evaluate the early post-operative course of kidney and intestinal biomarkers in patients following EVAR and their value for prediction of development of acute kidney injury or acute mesenteric ischemia.
Measured: 48hours post surgery
Secondary outcomes (3)
Local tissue perfusion and microcirculation as quantified by CEUS
Measured: 48 hours post surgery
Incidence of acute kidney injury (AKI)
Incidence of AKI within the first 48 hours as based on current KDIGO/AKIN recommendation (Kidney Disease Improving Global Outcomes - Clinical Practice Guideline for Acute Kidney Injury)
Measured: first 48 hours post surgery
Localization and incidence of intestinal ischemia
Measured: first 48 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2014
- Study completionNov 2014
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 IschemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Hans-Jürgen Schlitt, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915446
- Sponsor's protocol ID
- KISMED-001
- Acronym
- KISMED
- Status last verified
- Dec 2014
- First submitted
- 31 Jul 2013
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gocze I, Ehehalt K, Zeman F, Riquelme P, Pfister K, Graf BM, Bein T, Geissler EK, Kasprzak P, Schlitt HJ, Kellum JA, Hutchinson JA, Eggenhofer E, Renner P. Postoperative cellular stress in the kidney is associated with an early systemic gammadelta T-cell immune cell response. Crit Care. 2018 Jul 4;22(1):168. doi: 10.1186/s13054-018-2094-x.
PubMed 29973233
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney and Intestinal Markers for Early Detection of Organ Injury After Endovascular Aortic Repair - The KISMED Study
- ClinicalTrials.gov ID
- NCT01915446
- Acronym / sponsor ID
- KISMED / KISMED-001
- Keywords
- EVAR, endovascular aortic repair, acute kidney failure, mesenteric ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Aug 2013 (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 aims to investigate the predictive value of novel biomarkers and contrast-enhanced ultrasonography for early detection of abdominal end-organ (kidney and intestinum) hypoperfusion and ischemia in patients undergoing endovascular aortic repair (EVAR) for aortic aneurysm or dissection. In this context, patients will be monitored for renal biomarkers (TIMP-2, IGFBP7) and intestinal biomarkers (plasmatic intestinal fatty acid binding protein (i-FABP)) and local tissue perfusion will be assessed using contrast-enhanced ultrasonography (CEUS).
The ultimate goal of this study is an early identification of patients developing one or both of these complications, which may facilitate a timely intervention to improve outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing endovascular aortic repair in a University hospital
Key inclusion criteria (4 listed)
- Existence of an aortic aneurysm with need of repair as indicated by the treating vascular surgeon
- Aortic stenting involving the origin of both mesenteric (i.e. superior and inferior mesenteric arteries) and kidney arteries
- Central line is present to perform repeated blood collections
- Written informed consent is obtained.
Key exclusion criteria (5 listed)
- Pre-existing severe liver or kidney injury (defined as spontaneous international normalized ratio (INR) >2 or creatinine >2 mg/dl or renal-replacement therapy in the pre-operative course.)
- Known allergy to ultrasound contrast media (exclusion for the CEUS but not for marker evaluation)
- Anemia with hemoglobin concentration < 7g/dl
- Patients < 18 years of age
- Patients not able to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of biomarkers of abdominal organ injury (plasmatic i-FABP, TIMP-2, IGFBP7)
Time frame: 48hours post surgery
The primary objective of this study is to evaluate the early post-operative course of kidney and intestinal biomarkers in patients following EVAR and their value for prediction of development of acute kidney injury or acute mesenteric ischemia.
3 secondary outcomes
Local tissue perfusion and microcirculation as quantified by CEUS
Time frame: 48 hours post surgery
Incidence of acute kidney injury (AKI)
Time frame: first 48 hours post surgery
Localization and incidence of intestinal ischemia
Time frame: first 48 hours post surgery
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 18 Dec 2014.
- Derived from this study: PubMed 29973233Gocze I, Ehehalt K, Zeman F, Riquelme P, Pfister K, Graf BM, Bein T, Geissler EK, Kasprzak P, Schlitt HJ, Kellum JA, Hutchinson JA, Eggenhofer E, Renner P. Postoperative cellular stress in the kidney is associated with an early systemic gammadelta T-cell immune cell response. Crit Care. 2018 Jul 4;22(1):168. doi: 10.1186/s13054-018-2094-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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ischemia and Fatty Acid-Binding Proteins, run by University Hospital Regensburg 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 4 inclusion and 5 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 18 Dec 2014. 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?
Level of biomarkers of abdominal organ injury (plasmatic i-FABP, TIMP-2, IGFBP7) (time frame: 48hours post surgery). 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 NCT01915446, 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 18 Dec 2014.