Acute Kidney Injury, Premature Infant
Conditions
Keywords
Near Infrared Spectroscopy, Creatinine, Urine Output
Brief summary
This study will examine the relationship of oxygen levels, using Near-infrared spectroscopy (NIRS) monitoring, and kidney injury in infants born prematurely. NIRS is a skin sensor which detects the amount of oxygen going to different organs, most often used to monitor the brain and kidney.
Detailed description
This prospective, single-center study was conducted at UnityPoint Health-Meriter Hospital (Madison, WI, USA) in preterm neonates admitted to a level III NICU from April 2018 to August 2019. The primary study aim was to assess changes in RrSO2 with continuous renal NIRS monitoring to detect AKI during the first 7 days of age. The INVOS 5100 C (Somanetics, Troy, MI, USA) four channel NIRS monitors were used to measure RrSO2 (measured at the right or left flank) and Cerebral regional Somatic tissue Oxygenation (CrSO2; measured at the forehead) for all neonates. At each measurement site, for skin protection, subjects had a transparent Mepitel (with Safetac Technology, Norcross, GA) adhesive dressing placed with the adhesive neonatal NIRS sensor (INVOS OxyAlert NIRSensor, Covidien) adhered over the Mepitel dressing. Neither cerebral or kidney sensors were placed with ultrasound guidance. Tissue oxygenation was recorded every 3 seconds until 7 days of age, and the sensor was changed one time when the patient reached three to four days of age per the company's recommendation. There were no restrictions on positioning or handling of neonates; nurses re-positioned neonates every 3-6 hours per unit protocol to prevent skin pressure injuries. Researchers, staff, and parents were blinded to RrSO2 values.
Interventions
DEVICENear Infrared Spectroscopy
Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age.
Sponsors
University of Wisconsin, Madison
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 7 Days
Healthy volunteers
No
Inclusion criteria
* Preterm infants \< 32 weeks * Admitted to Unity Point Health(UPH) Meriter Newborn Intensive Care Unit (NICU) * Application of NIRS by 48 hours of age
Exclusion criteria
* Congenital anomaly of the kidney or urinary tract (CAKUT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal NIRS Tissue Oxygenation Differential | Up to 1 week | Comparison of Renal saturation (Rsat) in neonates with AKI to those without AKI. RSO2 will be recorded until 7 days of age. Median RSO2 for 1 week and median for individual days 2-7 will be calculated. The INVOS 5100 C (Somanetics, Troy, MI, USA) four channel NIRS monitors will be used to measure renal regional oxygenation (RrSO2) values for all neonates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal NIRS Values 4 Hours After Caffeine | At 4 hours after caffeine dose | Renal NIRS values 4 hours after caffeine broken down by baseline average |
| Correlation of Renal NIRS Values to Serum Creatinine | Days 1-7 of age | At each time a serum creatinine was collected, the RrSO2 value was recorded. |
| Correlation of Renal NIRS Values to Urine Output | Days 1-7 of age | In patients with urine output recorded, it was compared to RrSO2 values |
| Renal NIRS Values 6 Hours After Caffeine | At 6 hours after caffeine dose | Renal NIRS values 6 hours after caffeine broken down by baseline average |
| Renal NIRS Values 1 Hour After Caffeine | At 1 hour after caffeine dose | Renal NIRS values one hour after caffeine broken down by baseline average. |
| Renal NIRS Values 2 Hours After Caffeine | At 2 hours after caffeine dose | Renal NIRS values 2 hours after caffeine broken down by baseline average |
| Renal NIRS Values 3 Hours After Caffeine | At 3 hours after caffeine dose | Renal NIRS values 3 hours after caffeine broken down by baseline average |
| Baseline Renal NIRS Values Before Caffeine | Baseline (6 hours prior to caffeine dose) | these are the average renal NIRS values over 6 hours prior to a dose of caffeine broken down by percentage |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Acute Kidney Injury (AKI) Infants with No AKI diagnosis.
These infants will be monitored with NIRS
Near Infrared Spectroscopy: Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age. | 32 |
| Acute Kidney Injury (AKI) Infants diagnosed with AKI.
These infants will be monitored with NIRS
Near Infrared Spectroscopy: Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age. | 3 |
| Total | 35 |
Baseline characteristics
| Characteristic | No Acute Kidney Injury (AKI) | Total | Acute Kidney Injury (AKI) |
|---|---|---|---|
| Age, Continuous | 29.4 gestational age (weeks) | 27.2 gestational age (weeks) | 25 gestational age (weeks) |
| Birth Weight | 1135 grams | 945 grams | 655 grams |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 32 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 12 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 19 Participants | 1 Participants |
| Region of Enrollment United States | 32 participants | 35 participants | 3 participants |
| Sex: Female, Male Female | 13 Participants | 16 Participants | 3 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants | 0 Participants |
| Small for gestational age | 3 participants | 5 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 3 |
| other Total, other adverse events | 0 / 32 | 0 / 3 |
| serious Total, serious adverse events | 0 / 32 | 0 / 3 |
Outcome results
Primary
Renal NIRS Tissue Oxygenation Differential
Comparison of Renal saturation (Rsat) in neonates with AKI to those without AKI. RSO2 will be recorded until 7 days of age. Median RSO2 for 1 week and median for individual days 2-7 will be calculated. The INVOS 5100 C (Somanetics, Troy, MI, USA) four channel NIRS monitors will be used to measure renal regional oxygenation (RrSO2) values for all neonates.
Time frame: Up to 1 week
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| No Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | Day 3 RrSO2 | 60.4 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | Day 5 RrSO2 | 59.7 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | Day 2 RrSO2 | 62.5 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | Day 6 RrSO2 | 60 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | Day 4 RrSO2 | 59.1 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | Day 7 RrSO2 | 60.3 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | 1 week Median RSO2 | 60 percentage saturation |
| Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | Day 7 RrSO2 | 55.3 percentage saturation |
| Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | 1 week Median RSO2 | 32.4 percentage saturation |
| Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | Day 2 RrSO2 | 44.4 percentage saturation |
| Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | Day 3 RrSO2 | 30.8 percentage saturation |
| Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | Day 4 RrSO2 | 29.9 percentage saturation |
| Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | Day 5 RrSO2 | 29.2 percentage saturation |
| Acute Kidney Injury (AKI) | Renal NIRS Tissue Oxygenation Differential | Day 6 RrSO2 | 24 percentage saturation |
p-value: <0.001ANOVA
Secondary
Baseline Renal NIRS Values Before Caffeine
these are the average renal NIRS values over 6 hours prior to a dose of caffeine broken down by percentage
Time frame: Baseline (6 hours prior to caffeine dose)
Population: Out of 35 enrolled participants, 32 participants received total 156 doses of caffeine. Giving Caffeine was at the discretion of the attending physician.~This analysis is done by the dose of caffeine, and not the participant. Each row shows the number of doses given in that baseline percentage.~The caffeine doses have been de-identified from the participants so the number of participants in each row cannot be calculated from the currently recorded data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| No Acute Kidney Injury (AKI) | Baseline Renal NIRS Values Before Caffeine | Baseline <20% (12 caffeine doses) | 15.24 % oxygenation |
| No Acute Kidney Injury (AKI) | Baseline Renal NIRS Values Before Caffeine | Baseline 20-29.99% (16 caffeine doses) | 26.93 % oxygenation |
| No Acute Kidney Injury (AKI) | Baseline Renal NIRS Values Before Caffeine | Baseline 30-39.99% (18 caffeine doses) | 36.11 % oxygenation |
| No Acute Kidney Injury (AKI) | Baseline Renal NIRS Values Before Caffeine | Baseline 40-49.99% (13 caffeine doses) | 48.61 % oxygenation |
| No Acute Kidney Injury (AKI) | Baseline Renal NIRS Values Before Caffeine | Baseline 50-59.99% (21 caffeine doses) | 54.41 % oxygenation |
| No Acute Kidney Injury (AKI) | Baseline Renal NIRS Values Before Caffeine | Baseline >60% (76 caffeine doses) | 73.08 % oxygenation |
Secondary
Correlation of Renal NIRS Values to Serum Creatinine
At each time a serum creatinine was collected, the RrSO2 value was recorded.
Time frame: Days 1-7 of age
Population: All participants with serum creatinine values were included
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Acute Kidney Injury (AKI) | Correlation of Renal NIRS Values to Serum Creatinine | 0.81 mg/dL |
p-value: 0.1795% CI: [-0.07, 0.37]Pearson r correlation
Secondary
Correlation of Renal NIRS Values to Urine Output
In patients with urine output recorded, it was compared to RrSO2 values
Time frame: Days 1-7 of age
Population: All patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Acute Kidney Injury (AKI) | Correlation of Renal NIRS Values to Urine Output | 3 mL/kg/hour |
p-value: 0.3295% CI: [-0.11, 0.33]Pearson r correlation
Secondary
Renal NIRS Values 1 Hour After Caffeine
Renal NIRS values one hour after caffeine broken down by baseline average.
Time frame: At 1 hour after caffeine dose
Population: Out of 35 enrolled participants, 32 participants received total 156 doses of caffeine. Giving Caffeine was at the discretion of the attending physician.~This analysis is done by the dose of caffeine, and not the participant. Each row shows the number of doses given in that baseline percentage.~The caffeine doses have been de-identified from the participants so the number of participants in each row cannot be calculated from the currently recorded data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| No Acute Kidney Injury (AKI) | Renal NIRS Values 1 Hour After Caffeine | Doses with baseline <20% (12 caffeine doses) | 16.09 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 1 Hour After Caffeine | Doses with baseline 20-29.99% (16 caffeine doses) | 32.83 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 1 Hour After Caffeine | Doses with baseline 30-39.99% (18 caffeine doses) | 44.18 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 1 Hour After Caffeine | Doses with baseline 40-49.99% (13 caffeine doses) | 49.23 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 1 Hour After Caffeine | Doses with baseline 50-59.99% (21 caffeine doses) | 54.31 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 1 Hour After Caffeine | Doses with baseline >60% (76 caffeine doses) | 70.55 percentage saturation |
Comparison: Control group is Secondary analysis #4, baseline values before caffeine dose.p-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
Renal NIRS Values 2 Hours After Caffeine
Renal NIRS values 2 hours after caffeine broken down by baseline average
Time frame: At 2 hours after caffeine dose
Population: Out of 35 enrolled participants, 32 participants received total 156 doses of caffeine. Giving Caffeine was at the discretion of the attending physician.~This analysis is done by the dose of caffeine, and not the participant. Each row shows the number of doses given in that baseline percentage.~The caffeine doses have been de-identified from the participants so the number of participants in each row cannot be calculated from the currently recorded data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| No Acute Kidney Injury (AKI) | Renal NIRS Values 2 Hours After Caffeine | Doses with baseline <20% (12 caffeine doses) | 16.15 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 2 Hours After Caffeine | Doses with baseline 20-29.99% (16 caffeine doses) | 40.66 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 2 Hours After Caffeine | Doses with baseline 30-39.99% (18 caffeine doses) | 39.06 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 2 Hours After Caffeine | Doses with baseline 40-49.99% (13 caffeine doses) | 49.96 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 2 Hours After Caffeine | Doses with baseline 50-59.99% (21 caffeine doses) | 55.81 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 2 Hours After Caffeine | Doses with baseline >60% (76 caffeine doses) | 68.51 percentage saturation |
Comparison: Control group is secondary outcome #4, baseline values before caffeine dosep-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Renal NIRS Values 3 Hours After Caffeine
Renal NIRS values 3 hours after caffeine broken down by baseline average
Time frame: At 3 hours after caffeine dose
Population: Out of 35 enrolled participants, 32 participants received total 156 doses of caffeine. Giving Caffeine was at the discretion of the attending physician.~This analysis is done by the dose of caffeine, and not the participant. Each row shows the number of doses given in that baseline percentage.~The caffeine doses have been de-identified from the participants so the number of participants in each row cannot be calculated from the currently recorded data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| No Acute Kidney Injury (AKI) | Renal NIRS Values 3 Hours After Caffeine | Doses with baseline <20% (12 caffeine doses) | 17.3 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 3 Hours After Caffeine | Doses with baseline 20-29.99% (16 caffeine doses) | 36.12 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 3 Hours After Caffeine | Doses with baseline 30-39.99% (18 caffeine doses) | 40.4 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 3 Hours After Caffeine | Doses with baseline 40-49.99% (13 caffeine doses) | 50.6 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 3 Hours After Caffeine | Doses with baseline 50-59.99% (21 caffeine doses) | 58.05 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 3 Hours After Caffeine | Doses with baseline >60% (76 caffeine doses) | 66.55 percentage saturation |
Comparison: Comparison group is Secondary outcome #4, baseline caffeine values by subgroupp-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
Renal NIRS Values 4 Hours After Caffeine
Renal NIRS values 4 hours after caffeine broken down by baseline average
Time frame: At 4 hours after caffeine dose
Population: Out of 35 enrolled participants, 32 participants received total 156 doses of caffeine. Giving Caffeine was at the discretion of the attending physician.~This analysis is done by the dose of caffeine, and not the participant. Each row shows the number of doses given in that baseline percentage.~The caffeine doses have been de-identified from the participants so the number of participants in each row cannot be calculated from the currently recorded data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| No Acute Kidney Injury (AKI) | Renal NIRS Values 4 Hours After Caffeine | Doses with baseline <20% (12 caffeine doses) | 16.98 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 4 Hours After Caffeine | Doses with baseline 20-29.99% (16 caffeine doses) | 39.64 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 4 Hours After Caffeine | Doses with baseline 30-39.99% (18 caffeine doses) | 42.71 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 4 Hours After Caffeine | Doses with baseline 40-49.99% (13 caffeine doses) | 48.47 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 4 Hours After Caffeine | Doses with baseline 50-59.99% (21 caffeine doses) | 57.78 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 4 Hours After Caffeine | Doses with baseline >60% (76 caffeine doses) | 71.19 percentage saturation |
Comparison: Comparison group is secondary outcome #4, baseline values before caffeine dosep-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Renal NIRS Values 6 Hours After Caffeine
Renal NIRS values 6 hours after caffeine broken down by baseline average
Time frame: At 6 hours after caffeine dose
Population: Out of 35 enrolled participants, 32 participants received total 156 doses of caffeine. Giving Caffeine was at the discretion of the attending physician.~This analysis is done by the dose of caffeine, and not the participant. Each row shows the number of doses given in that baseline percentage.~The caffeine doses have been de-identified from the participants so the number of participants in each row cannot be calculated from the currently recorded data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| No Acute Kidney Injury (AKI) | Renal NIRS Values 6 Hours After Caffeine | Doses with baseline <20% (12 caffeine doses) | 15.4 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 6 Hours After Caffeine | Doses with baseline 20-29.99% (16 caffeine doses) | 35.18 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 6 Hours After Caffeine | Doses with baseline 30-39.99% (18 caffeine doses) | 40.62 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 6 Hours After Caffeine | Doses with baseline 40-49.99% (13 caffeine doses) | 49.97 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 6 Hours After Caffeine | Doses with baseline 50-59.99% (21 caffeine doses) | 55.8 percentage saturation |
| No Acute Kidney Injury (AKI) | Renal NIRS Values 6 Hours After Caffeine | Doses with baseline >60% (76 caffeine doses) | 70.09 percentage saturation |
Comparison: Comparison group is Secondary Outcome #4, baseline before dose of caffeine.p-value: <0.05Wilcoxon (Mann-Whitney)