Intensive Monitoring of Renal Function

NCT ID: NCT02657226

Last Updated: 2019-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15724 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-05-31

Brief 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.

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.

Conditions

Intensive Monitoring of Renal Function; Acute Kidney Injury

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Critically ill patient admitted to ICU
• Required vasopressor support or mechanical ventilation in the 24 hours from ICU admission

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

John Kellum

Director, Center for Critical Care Nephrology; Professor, Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 28527880 (View on PubMed)

Related Links

https://www.ncbi.nlm.nih.gov/pubmed/28527880

Related Info

Other Identifiers

PRO14120283

Identifier Type: -

Identifier Source: org_study_id