Major High Risk OperationsNCT02041403
RENAL RESISTIVE INDEX POST-OPERATIVE COMPLICATIONS IN MAJOR SURGERY?
An observational study of Major High Risk Operations and Renal Resistive Index, run by Istituto Clinico Humanitas at 2 sites in Italy.
Trial summary
An observational trial aiming to verify whether does any relationship exist between renal resistive index and postoperative outcome in major high risk surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major High Risk Operations, Renal Resistive Index, Outcome
- How many people
- 218 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2012to Jul 2013
- 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 submitted to major high risk surgery
Who may be able to join
- age > 18 years
- major surgical operations
Who cannot join
- age < 18 years
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Sant'Ambrogio Clinical Institute - Cardiac Anesthesia Unit
Milan, Milano, 20100
Humanitas Research Hospital - Dept. Anesthesia and Intensive Care Unit
Rozzano, Milano, 20089
About this study
Official title: MAY RENAL RESISTIVE INDEX BE AN EARLY PREDICTIVE TOOL OF POST-OPERATIVE COMPLICATIONS IN MAJOR SURGERY?
An observational trial aiming to verify whether does any relationship exist between renal resistive index and postoperative outcome in major high risk surgery
Read the detailed description
Renal resistive index was measured just after major high risk operations and then patients were observed searching for any surgical and medical-related complications during the first post-operative week
- Conditions
- Major High Risk Operations, Renal Resistive Index, Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Renal resistive Index | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Recording any postoperative complication occurred within the first postoperative week
Measured: 7 post-operative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major High Risk OperationsStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrico Giustiniano, MD, Principal investigator, Humanitas Research Hospital -Dept. Anesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041403
- Sponsor's protocol ID
- CE ICH-158/12
- Status last verified
- Jan 2014
- First submitted
- 18 Jan 2014
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAY RENAL RESISTIVE INDEX BE AN EARLY PREDICTIVE TOOL OF POST-OPERATIVE COMPLICATIONS IN MAJOR SURGERY?
- ClinicalTrials.gov ID
- NCT02041403
- Acronym / sponsor ID
- CE ICH-158/12
- Conditions
- Major High Risk Operations, Renal Resistive Index, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Jan 2014 (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.
An observational trial aiming to verify whether does any relationship exist between renal resistive index and postoperative outcome in major high risk surgery
Detailed description
Renal resistive index was measured just after major high risk operations and then patients were observed searching for any surgical and medical-related complications during the first post-operative week
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal resistive Index | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients submitted to major high risk surgery
Key inclusion criteria (2 listed)
- age > 18 years
- major surgical operations
Key exclusion criteria (1 listed)
- age < 18 years
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
Complications
Time frame: 7 post-operative days
Recording any postoperative complication occurred within the first postoperative week
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 Jan 2014.
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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.
Enrico Giustiniano, MD principal investigator
Humanitas Research Hospital -Dept. Anesthesia and Intensive Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major High Risk Operations and Renal Resistive Index, run by Istituto Clinico Humanitas at 2 sites in Italy.
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 2 inclusion and 1 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 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Complications (time frame: 7 post-operative days). 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 23 Jan 2014.