Intensive Monitoring of Renal Function

NCT02657226 | Completed Results

• 1 other identifier: PRO14120283
• Study Type: observational
• Target: 15,724
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intensive Monitoring of Renal Function; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days from ICU admission

Secondary Outcomes (3)

• Mortality

  30 days

• Length of Stay in ICU

  30 days

• Hospital Length of Stay

  30 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted at the University of Pittsburgh Medical Center ICU or hospital.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• C. R. Bard: collaborator

Related Publications (1)

• 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.

  PMID: 28527880 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

This is a retrospective observational study.

Results Point of Contact

• Title: Dr. John Kellum
• Organization: The University of Pittsburgh

kas287@pitt.edu

4123834202

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Critical Care Nephrology; Professor, Critical Care Medicine

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: January 15, 2016
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 28, 2019
• Results First Posted: June 28, 2019

Record last verified: 2019-06