Intensive Monitoring of Renal FunctionNCT02657226
Intensive Monitoring of Renal Function
An observational study of Intensive Monitoring of Renal Function and Acute Kidney Injury, run by University of Pittsburgh.
Trial summary
This study aims to examine the association between monitoring (Intensive and non-intensive) of renal function (urine output, serum creatinine) and outcomes among critically ill patients such as Acute Kidney Injury (AKI) and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Monitoring of Renal Function, Acute Kidney Injury
- How many people
- 15,724 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to May 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Adult patients admitted at the University of Pittsburgh Medical Center ICU or hospital.
Who may be able to join
- Critically ill patient admitted to ICU
- Required vasopressor support or mechanical ventilation in the 24 hours from ICU admission
Who cannot join
- History of chronic dialysis and/or renal transplant
- Baseline serum creatinine >= 4 mg/dl
- Insufficient data to determine AKI stage in the 7 days from ICU admission
- Died within 48 hours from ICU admission
- ICU duration <2880 minutes
About this study
Official title: Association Between Intensive Monitoring of Renal Function and Outcomes in Critically Ill Patients
This study aims to examine the association between monitoring (Intensive and non-intensive) of renal function (urine output, serum creatinine) and outcomes among critically ill patients such as Acute Kidney Injury (AKI) and mortality.
Read the detailed description
Intensive monitoring of renal function provides an early opportunity to modify or attenuate certain risk factors (e.g., nephrotoxin exposure) for AKI. Intensive monitoring of urine output (UO) provides a real-time continuous assessment of renal function in the ICU. However, the association between intensive monitoring and less-intensive monitoring of urine output, with or without close monitoring of serum creatinine (sCr), on susceptibility to AKI and outcomes from AKI are unknown. Our preliminary data indicates that intensive monitoring of UO is associated with lower hospital mortality as compared to less-intensive monitoring for patients that develop AKI. If intensive monitoring of renal function is associated with lower risk of AKI and improved outcomes from AKI, then such monitoring techniques could be widely used in hospitalized patients including non-intensive care settings to either prevent AKI or progression of AKI.
Therefore, this observational retrospective cohort study aims to compare the outcomes of patients undergoing intensive monitoring of renal function (UO and/or sCr) with those of patients undergoing less intensive monitoring. Outcomes will include mortality within 30 days of ICU admission among critically ill patients with and without AKI. Development of severe AKI within 7 days of ICU admission and fluid overload on any ICU day in patients who develop severe AKI (KDIGO stage 3) will also be assessed.
This study will utilize a large, heterogeneous cohort (n=~54,800) of critically ill patients admitted to the ICU over 8 year period at the University of Pittsburgh Medical Center. The study population will consist of patients who receive intensive monitoring of UO (defined as measured at least every 2 hours within the first 48 hours of ICU admission) and strict creatinine measurement (defined as at least daily). Patients who fail to meet criteria for intensive monitoring will be controls (less-intensive monitoring group). AKI will be diagnosed according to the KDIGO stage 1-3 criteria over a 7-day period. Mortality at 30-days from ICU admission will be ascertained using the social security death master file. In order to account for indication bias, a propensity score for intensive monitoring will be built using various risk factors. Risk and severity of illness-adjusted estimates will be generated for susceptibility to AKI and mortality from AKI between intensive and less-intensive monitoring groups.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Monitoring of Renal Function | Urine output measurements recorded at least every 2 hours within the first 48 hours of ICU admission and serum creatinine measurements recorded daily for 3 days following ICU admission. | |
| Less-Intensive Monitoring of Renal Function | Urine output measurements with gaps of more than 3 hours recorded during the first 48 hours of ICU admission and fewer than 3 days of serum creatinine measurements after ICU admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Acute Kidney Injury (AKI)
We classified AKI according to the maximum Kidney Disease Improving Global Outcomes criteria met during the 7 days after ICU admission using both SC and UO criteria. Admission creatinine levels were the first creatinine value recorded for the index hospital admission. Reference creatinine level was taken as the baseline creatinine level when available; otherwise, it was the lowest between admission creatinine level or creatinine level recorded in the 24 hours following ICU admission estimated using MDRD equation. For all analyses, we used moderate to severe AKI defined as stage 2-3. For UO criteria, at least every 6 hours data was required to stage AKI regardless of whether the patient had intensive or nonintensive UO monitoring overall.Odds ratio were measured between two groups.Odds ratios were determined using multivariable models for intensive vs non-intensive UO and between intensive vs non-intensive creatinine monitoring groups.
Measured: 7 days from ICU admission
Secondary outcomes (3)
Mortality
Hazard Ratios were measured to detect the risk of mortality at 30 days from ICU admission.
Measured: 30 days
Length of Stay in ICU
Patients with and without AKI were compared among urine output group for duration of stay in ICU and hospital.
Measured: 30 days
Hospital Length of Stay
Hospital length of Stay was measured among urine output group and reported as median (Inter-Quartile Range).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Monitoring of Renal FunctionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Retrospective
- Enrolment
- 15,724 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- C. R. Bard
- Responsible party
- Principal investigator, John Kellum, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657226
- Sponsor's protocol ID
- PRO14120283
- Status last verified
- Jun 2019
- First submitted
- 29 Sep 2015
- Last updated
- 28 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jin K, Murugan R, Sileanu FE, Foldes E, Priyanka P, Clermont G, Kellum JA. Intensive Monitoring of Urine Output Is Associated With Increased Detection of Acute Kidney Injury and Improved Outcomes. Chest. 2017 Nov;152(5):972-979. doi: 10.1016/j.chest.2017.05.011. Epub 2017 May 17.
PubMed 28527880
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Intensive Monitoring of Renal Function and Outcomes in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02657226
- Acronym / sponsor ID
- PRO14120283
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,724 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- C. R. Bard
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Posted 28 Jun 2019
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 examine the association between monitoring (Intensive and non-intensive) of renal function (urine output, serum creatinine) and outcomes among critically ill patients such as Acute Kidney Injury (AKI) and mortality.
Detailed description
Intensive monitoring of renal function provides an early opportunity to modify or attenuate certain risk factors (e.g., nephrotoxin exposure) for AKI. Intensive monitoring of urine output (UO) provides a real-time continuous assessment of renal function in the ICU. However, the association between intensive monitoring and less-intensive monitoring of urine output, with or without close monitoring of serum creatinine (sCr), on susceptibility to AKI and outcomes from AKI are unknown. Our preliminary data indicates that intensive monitoring of UO is associated with lower hospital mortality as compared to less-intensive monitoring for patients that develop AKI. If intensive monitoring of renal function is associated with lower risk of AKI and improved outcomes from AKI, then such monitoring techniques could be widely used in hospitalized patients including non-intensive care settings to either prevent AKI or progression of AKI.
Therefore, this observational retrospective cohort study aims to compare the outcomes of patients undergoing intensive monitoring of renal function (UO and/or sCr) with those of patients undergoing less intensive monitoring. Outcomes will include mortality within 30 days of ICU admission among critically ill patients with and without AKI. Development of severe AKI within 7 days of ICU admission and fluid overload on any ICU day in patients who develop severe AKI (KDIGO stage 3) will also be assessed.
This study will utilize a large, heterogeneous cohort (n=~54,800) of critically ill patients admitted to the ICU over 8 year period at the University of Pittsburgh Medical Center. The study population will consist of patients who receive intensive monitoring of UO (defined as measured at least every 2 hours within the first 48 hours of ICU admission) and strict creatinine measurement (defined as at least daily). Patients who fail to meet criteria for intensive monitoring will be controls (less-intensive monitoring group). AKI will be diagnosed according to the KDIGO stage 1-3 criteria over a 7-day period. Mortality at 30-days from ICU admission will be ascertained using the social security death master file. In order to account for indication bias, a propensity score for intensive monitoring will be built using various risk factors. Risk and severity of illness-adjusted estimates will be generated for susceptibility to AKI and mortality from AKI between intensive and less-intensive monitoring groups.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Monitoring of Renal Function | – | –Urine output measurements recorded at least every 2 hours within the first 48 hours of ICU admission and serum creatinine measurements recorded daily for 3 days following ICU admission. |
| Less-Intensive Monitoring of Renal Function | – | –Urine output measurements with gaps of more than 3 hours recorded during the first 48 hours of ICU admission and fewer than 3 days of serum creatinine measurements after ICU admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted at the University of Pittsburgh Medical Center ICU or hospital.
Key inclusion criteria (2 listed)
- Critically ill patient admitted to ICU
- Required vasopressor support or mechanical ventilation in the 24 hours from ICU admission
Key exclusion criteria (5 listed)
- History of chronic dialysis and/or renal transplant
- Baseline serum creatinine >= 4 mg/dl
- Insufficient data to determine AKI stage in the 7 days from ICU admission
- Died within 48 hours from ICU admission
- ICU duration <2880 minutes
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
Detection of Acute Kidney Injury (AKI)
Time frame: 7 days from ICU admission
We classified AKI according to the maximum Kidney Disease Improving Global Outcomes criteria met during the 7 days after ICU admission using both SC and UO criteria. Admission creatinine levels were the first creatinine value recorded for the index hospital admission. Reference creatinine level was taken as the baseline creatinine level when available; otherwise, it was the lowest between admission creatinine level or creatinine level recorded in the 24 hours following ICU admission estimated using MDRD equation. For all analyses, we used moderate to severe AKI defined as stage 2-3. For UO criteria, at least every 6 hours data was required to stage AKI regardless of whether the patient had intensive or nonintensive UO monitoring overall.Odds ratio were measured between two groups.Odds ratios were determined using multivariable models for intensive vs non-intensive UO and between intensive vs non-intensive creatinine monitoring groups.
3 secondary outcomes
Mortality
Time frame: 30 days
Length of Stay in ICU
Time frame: 30 days
Hospital Length of Stay
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28527880Jin K, Murugan R, Sileanu FE, Foldes E, Priyanka P, Clermont G, Kellum JA. Intensive Monitoring of Urine Output Is Associated With Increased Detection of Acute Kidney Injury and Improved Outcomes. Chest. 2017 Nov;152(5):972-979. doi: 10.1016/j.chest.2017.05.011. Epub 2017 May 17.
- Related InfoLink provided by the sponsor.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Monitoring of Renal Function and Acute Kidney Injury, run by University of Pittsburgh.
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 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 28 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 28 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Detection of Acute Kidney Injury (AKI) (time frame: 7 days from ICU admission). 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 NCT02657226, 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 28 Jun 2019.