Kidney InjuryNCT05146947
Intraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy
A study testing near infrared spectroscopy in people with Kidney Injury, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Intra-operative NIRS measurements of kidney during partial nephrectomy, after reperfusion, for monitoring ischemia and prediction of postoperative renal dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Injury
- What is being tested?
- near infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 28 Feb 2024
- Phase
- Interventional
- 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
- Candidates for partial nephrectomy at Tel Aviv Medical Center who will consent to participate.
Who cannot join
- Patients unable to give consent,
- Patients who were lost to follow up during the first 7 post-operative days.
Trial locations and contacts
No sites are listed yet.
About this study
Intra-operative NIRS measurements of kidney during partial nephrectomy, after reperfusion, for monitoring ischemia and prediction of postoperative renal dysfunction.
- Conditions
- Kidney Injury
- Being tested
- near infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near infrared spectroscopyDevice
near infrared spectroscopy monitoring on kidney after reperfusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
An increase in serum creatinine by 0.3mg/dL or more within 48 hours compared with admission creatinine level or an increase in serum creatinine above 1.5 times baseline within 7 days of admission
Measured: 7 days post operative and during 6 months post-surgery.
Secondary outcomes (1)
Surgical complications
Vascular/Bleeding ect.
Measured: 7 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Orr Goren, Dr, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146947
- Sponsor's protocol ID
- TASMC-21-OG-0327-21-CTIL
- Status last verified
- Dec 2021
- First submitted
- 20 Nov 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT05146947
- Acronym / sponsor ID
- TASMC-21-OG-0327-21-CTIL
- Conditions
- Kidney Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 7 Dec 2021 (actual)
- 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.
Intra-operative NIRS measurements of kidney during partial nephrectomy, after reperfusion, for monitoring ischemia and prediction of postoperative renal dysfunction.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Candidates for partial nephrectomy at Tel Aviv Medical Center who will consent to participate.
Key exclusion criteria (2 listed)
- Patients unable to give consent,
- Patients who were lost to follow up during the first 7 post-operative days.
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 |
|---|---|---|
| near infrared spectroscopynear infrared spectroscopy monitoring on kidney after reperfusion | Device | – |
Primary outcome
Acute Kidney Injury
Time frame: 7 days post operative and during 6 months post-surgery.
An increase in serum creatinine by 0.3mg/dL or more within 48 hours compared with admission creatinine level or an increase in serum creatinine above 1.5 times baseline within 7 days of admission
1 secondary outcome
Surgical complications
Time frame: 7 days post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Orr Goren, Dr principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing near infrared spectroscopy in people with Kidney Injury, run by Tel-Aviv Sourasky Medical Center.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orr Goren, Dr (+972527360972, org@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (time frame: 7 days post operative and during 6 months post-surgery.). 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 7 Dec 2021.