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临床试验/NCT07743099
NCT07743099已完成不适用

Renal Oxygen Saturation Measured by Near-Infrared Spectroscopy for the Early Recognition of Acute Kidney Injury in Asphyxiated Neonates Undergoing Therapeutic Hypothermia: A Prospective Observational Cohort Study

Agah Bahadır Öztürk,MD1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
Renal Regional Oxygen Saturation Measured by Near-Infrared Spectroscopy

研究概览

简要总结

This prospective, single-center observational cohort study evaluated whether continuous cerebral and bilateral renal near-infrared spectroscopy (NIRS) monitoring during therapeutic hypothermia distinguishes term neonates with hypoxic-ischemic encephalopathy (HIE) who develop acute kidney injury (AKI) from those who do not. Forty-six neonates who received whole-body therapeutic hypothermia for HIE were enrolled and monitored continuously for 72 hours. Regional oxygen saturation was recorded at three sites: the cerebral cortex and both kidneys. Acute kidney injury was classified after the monitoring period using serum creatinine-based criteria, and participants were assigned to an AKI group or a non-AKI group. The primary objective was to compare regional oxygen saturation between the two groups. Serum and urinary indices of tubular function were assessed at 24, 48, and 72 hours as secondary measures.

详细描述

Acute kidney injury is among the most frequent organ complications of perinatal asphyxia, and serum creatinine rises only after substantial functional loss has already occurred. Near-infrared spectroscopy provides continuous, non-invasive measurement of regional tissue oxygen saturation and may detect renal compromise earlier than conventional biochemical markers, but data in neonates undergoing therapeutic hypothermia remain limited.

This single-center prospective observational cohort study was conducted in the neonatal intensive care unit of Kayseri City Training and Research Hospital, Kayseri, Türkiye. Consecutive neonates with hypoxic-ischemic encephalopathy who began whole-body therapeutic hypothermia within 6 hours of birth were enrolled. All clinical management followed the unit's pre-existing standing protocol for therapeutic hypothermia and was not assigned, modified, or withheld for research purposes. Under that routine protocol, core temperature was maintained at 33.5 °C for 72 hours with servo-controlled feedback, followed by rewarming at 0.25 °C per hour; all neonates received ampicillin and cefotaxime because of infection risk, antibiotics were discontinued after rewarming in neonates without signs of infection, and aminoglycosides were not administered to any neonate owing to their recognized renal toxicity. The investigators recorded, but did not direct, clinical care.

Regional oxygen saturation was recorded continuously across the 72-hour cooling period using a cerebral/somatic oximeter. A neonatal sensor was placed on the right lateral forehead for cerebral measurement, and bilateral sensors were placed lateral to the lumbar spine at the T12-L2 vertebral level for renal measurement. Sensor position and skin integrity were checked every 4 to 6 hours. Recordings were time-synchronized with pulse oximetry and averaged into 6-hour intervals.

Serum and spot urine samples were obtained at 24, 48, and 72 hours for electrolytes and creatinine, from which fractional excretion of sodium and potassium, tubular reabsorption of phosphate, and urinary calcium/creatinine and magnesium/creatinine ratios were derived. Acute kidney injury was classified after the monitoring period using modified pediatric RIFLE criteria together with a neonatal-specific serum creatinine decline-rate criterion. Participants were then assigned to an AKI group or a non-AKI group, and regional oxygen saturation was compared between them.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Minutes 至 6 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age 36 weeks or more.
  • Birth weight 2,000 g or more.
  • Initiation of whole-body therapeutic hypothermia within 6 hours of birth.
  • Diagnosis of hypoxic-ischemic encephalopathy, defined by one or more of the following: cord or first-hour arterial pH 7.0 or below, or base excess -16 mmol/L or lower; 10-minute Apgar score 5 or below, or ongoing resuscitation requirement; amplitude-integrated EEG abnormality (lower margin below 5 μV, and/or upper margin below 10 μV, and/or seizure activity); modified Sarnat and Sarnat moderate-to-severe grading, or Thompson score above
  • Written informed consent provided by a parent or legal guardian.

排除标准

  • Gestational age below 36 weeks.
  • Birth weight below 2,000 g.
  • Age greater than 6 hours at initiation of therapeutic hypothermia.
  • Congenital renal anomaly.
  • Uncontrolled persistent pulmonary hypertension, or another life-threatening cardiovascular or respiratory condition.
  • Major congenital anomaly, including trisomy 13, trisomy 18, or multiple organ malformations.
  • Uncontrolled life-threatening hemorrhage, including intracranial hemorrhage.

研究组 & 干预措施

Group 1

Acute Kidney Injury (n=12) - Neonates with HIE undergoing therapeutic hypothermia who met acute kidney injury criteria during the first 72 hours; continuous cerebral and bilateral renal NIRS monitoring.

干预措施: 1- Continuous Cerebral Near-Infrared Spectroscopy (Diagnostic Test)

Group 1

Acute Kidney Injury (n=12) - Neonates with HIE undergoing therapeutic hypothermia who met acute kidney injury criteria during the first 72 hours; continuous cerebral and bilateral renal NIRS monitoring.

干预措施: 2- Continuous Bilateral Renal Near-Infrared Spectroscopy (Diagnostic Test)

Group 2

No Acute Kidney Injury (n=34) - Neonates with HIE undergoing therapeutic hypothermia who did not meet acute kidney injury criteria; identical monitoring.

干预措施: 1- Continuous Cerebral Near-Infrared Spectroscopy (Diagnostic Test)

Group 2

No Acute Kidney Injury (n=34) - Neonates with HIE undergoing therapeutic hypothermia who did not meet acute kidney injury criteria; identical monitoring.

干预措施: 2- Continuous Bilateral Renal Near-Infrared Spectroscopy (Diagnostic Test)

结局指标

主要结局

Renal Regional Oxygen Saturation Measured by Near-Infrared Spectroscopy

时间窗: Continuously throughout the 72-hour therapeutic hypothermia period, summarized as 6-hour mean values and as daily mean values for Days 1, 2, and 3.

Description: Renal regional oxygen saturation recorded by near-infrared spectroscopy from bilateral sensors (left kidney, right kidney, and the mean of the two), compared between neonates who developed acute kidney injury and those who did not. Unit of measure: percent (%).

次要结局

  • Cerebral Regional Oxygen Saturation Measured by Near-Infrared Spectroscopy(Continuously throughout the 72-hour therapeutic hypothermia period, summarized as 6-hour mean values and as daily mean values for Days 1, 2, and 3.)
  • Serum Creatinine Concentration(At 24, 48, and 72 hours after initiation of therapeutic hypothermia.)
  • Renal Tubular Function Indices(At 24, 48, and 72 hours after initiation of therapeutic hypothermia.)
  • Urinary Calcium/Creatinine and Magnesium/Creatinine Ratios(At 24, 48, and 72 hours after initiation of therapeutic hypothermia.)
  • Systolic, Diastolic, and Mean Arterial Blood Pressure(Throughout the 72-hour therapeutic hypothermia period, summarized as 6-hour mean values.)

研究者

发起方
Agah Bahadır Öztürk,MD
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Agah Bahadır Öztürk,MD

Principal Investigator, Department of Pediatrics

Kayseri City Hospital

研究点 (1)

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