Trial Outcomes & Findings for Intensive Monitoring of Renal Function (NCT NCT02657226)

NCT ID: NCT02657226

Last Updated: 2019-06-28

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 15724 participants
• Primary outcome timeframe: 7 days from ICU admission
• Results posted on: 2019-06-28

Participant Flow

This is an observational study. Hence, no prospective enrollment was performed. Collected data was analysed on patients meeting inclusion criteria for the study periof from year 2000 to 2008.

Participant milestones

Measure	Study Population Undergoing Urine Output and Serum Creatinine We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of \> 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.
Overall Study STARTED	15724
Overall Study COMPLETED	15724
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intensive Monitoring of Renal Function

Baseline characteristics by cohort

Measure	Study Population Undergoing Urine Output and Serum Creatinine n=15724 Participants We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of \> 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	6796 Participants n=5 Participants
Sex: Female, Male Male	8928 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American	1164 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	12276 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2284 Participants n=5 Participants
Region of Enrollment United States	15724 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days from ICU admission

Population: All patients receiving UO or SC monitoring

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.

Outcome measures

Measure	Intensive vs Non-Intensive UO Monitoring n=15724 Participants We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of \> 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.	Intensive vs Non-Intensive SC Monitoring n=15724 Participants We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of \> 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.
Detection of Acute Kidney Injury (AKI) Intensive monitoring urine output	1.22 Odds Ratio Interval 1.11 to 1.35	1.22 Odds Ratio Interval 1.11 to 1.35
Detection of Acute Kidney Injury (AKI) Intensive monitoring serum creatinine	1.11 Odds Ratio Interval 1.0 to 1.24	1.11 Odds Ratio Interval 1.0 to 1.24

SECONDARY outcome

Timeframe: 30 days

Population: Intensive monitoring by urine output and serum creatinine among AKI population is reported.

Hazard Ratios were measured to detect the risk of mortality at 30 days from ICU admission.

Outcome measures

Measure	Intensive vs Non-Intensive UO Monitoring n=15724 Participants We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of \> 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.	Intensive vs Non-Intensive SC Monitoring We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of \> 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.
Mortality Intensive monitoring Serum Creatinine	1.10 Hazard Ratio Interval 0.98 to 1.24	—
Mortality Intensive monitoring Urine Output	0.90 Hazard Ratio Interval 0.81 to 0.99	—

SECONDARY outcome

Timeframe: 30 days

Population: Median (Inter-Quartile Range) were reported.

Patients with and without AKI were compared among urine output group for duration of stay in ICU and hospital.

Outcome measures

Measure	Intensive vs Non-Intensive UO Monitoring n=15724 Participants We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of \> 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.	Intensive vs Non-Intensive SC Monitoring We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of \> 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.
Length of Stay in ICU Uo Monitoring AKI	8 days Interval 5.0 to 15.0	—
Length of Stay in ICU UO Monitoring No AKI	5 days Interval 4.0 to 10.0	—

SECONDARY outcome

Timeframe: 30 days

Hospital length of Stay was measured among urine output group and reported as median (Inter-Quartile Range).

Outcome measures

Measure	Intensive vs Non-Intensive UO Monitoring n=15724 Participants We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of \> 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.	Intensive vs Non-Intensive SC Monitoring We stratified patients into two overlapping cohorts: those who received UO monitoring and those who received SC monitoring. We further subdivided each cohort into an intensive monitoring group and a less intensive monitoring group. UO intensive monitoring was defined as hourly recordings and no gaps of \> 3 hours for the initial 48 hours after ICU admission, whereas less intensive UO monitoring was defined as patients not meeting intensive monitoring criteria regardless of UO information in the 7 days following ICU admission. SC intensive monitoring was defined as having 3 calendar days of SC data (at least one measure per day) after ICU admission, whereas less intensive SC monitoring was defined as patients not meeting intensive monitoring criteria regardless of SC monitoring availability in the 7 days following ICU admission.
Hospital Length of Stay UO Monitoring AKI	17 days Interval 11.0 to 29.0	—
Hospital Length of Stay UO Monitoring no AKI	14 days Interval 9.0 to 24.0	—

Adverse Events

Study Population Undergoing Urine Output and Serum Creatinine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Kellum

The University of Pittsburgh

Phone: 4123834202

Email: kas287@pitt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place