Acute Kidney InjuryNCT03617055
Acute Kidney Injury in Newborns With Perinatal Asphyxia
An observational study of Acute Kidney Injury, run by Assiut University.
Trial summary
The aim of the study is to investigate the role of serum cystatin C (sCysC) as an early predictor for both diagnosis and short term outcome evaluation of acute kidney injury (AKI) in neonates with perinatal asphyxia admitted to Neonatal Intensive Care Unit (NICU) of Assiut University Children Hospital Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- serum cystatin c
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: all full term neonates with documented perinatal asphyxiaby by one of the following indicators: (i) Presence of a sentinel hypoxic event immediately before or during delivery; (ii) History of fetal distress (bradycardia, late decelerations, absence of heart rate variability); (iii) Need for neonatal resuscitation at delivery; (iv) 1-min Apgar score <3 or 5-min Apgar score <7; or metabolic acidosis (BE > 10 in cord blood).
Who may be able to join
- all full term neonates who are admitted to neonatal intensive care unit of Assiut University Children Hospital through the period from Jan. 2019 to Jan. 2020 with documented perinatal asphyxia
Who cannot join
- preterm neonates < 37 weeks, neonates who died within the first 24 hours of admission, neonates with any congenital anomalies like skeletal, renal or urinary tract, neonates with AKI for any cause other than asphyxia and neonates with maternal history of renal failure .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Early Predictor of Acute Kidney Injury in Newborns With Perinatal Asphyxia
The aim of the study is to investigate the role of serum cystatin C (sCysC) as an early predictor for both diagnosis and short term outcome evaluation of acute kidney injury (AKI) in neonates with perinatal asphyxia admitted to Neonatal Intensive Care Unit (NICU) of Assiut University Children Hospital
Read the detailed description
Acute Kidney Injury is defined as the inability of the kidneys to excrete nitrogenous waste products and maintain fluid and electrolyte homeostasis. It is fairly common in newborn population and is a major contributor factor of neonatal mortality and morbidity.
The most common form of Acute Kidney Injury in neonates is prerenal failure due to renal hypo-perfusion or ischemia. Pre-renal failure may result in intrinsic kidney failure if it is not treated promptly. The kidneys of neonates are particularly susceptible to hypo-perfusion because of the physiologic characteristics of neonatal kidneys, including high renal vascular resistance, high plasma renin activity, low glomerular filtration, decreased intra-cortical perfusion rate and decreased reabsorption of sodium in the proximal tubules in the first days of a neonatal life. Thus, newborn infants are vulnerable to acute tubular necrosis or cortical necrosis.
The cause of Acute Kidney Injury in neonates is of multi-factorial etiology and, usually, there is one or more associated contributing factor. In most studies, perinatal asphyxia and sepsis are the most commonly associated conditions.
Perinatal asphyxia is defined as abnormal neurological incident resulting in neonatal hypoxic ischemic encephalopathy , which occurs usually due to brain hypoxia and ischemic incidents. Perinatal asphyxia can result in multi-organ dysfunction through redirection of cardiac output to maintain cerebral, cardiac, and adrenal perfusion while potentially compromising perfusion to non-vital organs including kidneys, this causing Acute Kidney Injury.
The incidence of Acute Kidney Injury after Perinatal asphyxia in term neonates was shown to be around 30% to 56%. Early detection of Acute Kidney Injury could optimize and improve patient outcomes. therefore, the use of biomarkers to predict renal damage has been of interest. Serum creatinine is the most commonly used clinical measure of renal function; however, it is a poor diagnostic marker and its utility is further questionable in neonates since kidneys undergo maturational changes in postnatal period.
Human Cystatin C is a low molecular weight protein, belonging to the cystatin superfamily of protease inhibitors, which is produced at a constant rate in all nucleated cells. Cystatin C is freely filtered through the glomerular membrane, then completely reabsorbed and degraded by the proximal tubule. Serum Cystatin C is being promoted as a more accurate estimate of neonatal glomerular filtration rate.
Acute Kidney Injury was diagnosed on the basis of changes in the serum creatinine level according to the modified neonatal Acute Kidney Injury of Kidney Disease Improving Global Outcome definition (Table 1). AKI was defined as an increase in the serum creatinine level by ≥ 0.3 mg/dL within 48 hours or ≥ 1.5 times from the baseline within 7 days.
Newborns are unique in that the serum creatinine level immediately after birth often reflects maternal levels. Studies have reported that the mean serum creatinine level in preterm infants rises during the first two days of postnatal life, reaches a plateau for a few days, and then decreases thereafter .Therefore, the baseline serum creatinine level was defined as the lowest previous serum creatinine level after 24 hours of age.
TABLE 1 Acute Kidney Injury of Kidney Disease Improving Global Outcome definition:
Stage serum creatinine Urine Output 0 No change or rise < 0.3 mg/dL. ≥ 0.5 mL/kg/h.
- rise ≥ 0.3 mg/dL within 48 h or rise ≥1.5-1.9 × reference level* within 7 days. < 0.5 mL/kg/h for 6 to 12 h.
- rise ≥ 2.0-2.9 × reference level * < 0.5 mL/kg/h for ≥ 12 h.
- rise ≥ 3 × reference level * or serum creatinine level ≥ 2.5 mg/dL or Receipt of dialysis. < 0.3 mL/kg/h for ≥ 24 h or anuria for ≥ 12 h.
- Reference level will be defined as the lowest previous serum creatinine.
The goal of Acute Kidney Injury management in newborns is to maintain homeostasis until the renal functions return, and is accomplished by addressing fluid and electrolyte imbalance, nutritional needs, and acidosis.Unfortunately, available data on the long-term outcome of neonatal Acute Kidney Injury patients is limited.
The short-term outcome of therapy for Acute Kidney Injury in newborns is dependent on the underlying etiology of Acute Kidney Injury, the involvement of other organs and the availability of renal replacement therapy. As expected, mortality is more frequent and morbidity is much worse in neonates with multi-organ failure.
- Conditions
- Acute Kidney Injury
- Being tested
- serum cystatin c
- Keywords
- kidney injury, asphyxia,cystatin c
- Medical subject headings
- Acute Kidney Injury, Asphyxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum cystatin cDiagnostic test
Blood sample for serum cystatin c will be taken on the first and third days of life for all neonates with clinical or laboratory signs of perinatal asphyxia who are admitted to NICU for early detection of AKI in the study group.
What is being measured
The primary outcome is the main question the study is designed to answer.
serum cystatin C (sCysC) as an early predictor of acute kidney injury (AKI) in neonates with perinatal asphyxia.
measuring serum cystatin c in neonates with perinatal asphyxia
Measured: one year
Secondary outcomes (1)
is to determine the incidence of Acute kidney injury in neonates with perinatal asphyxia.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. A. Sabra, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617055
- Sponsor's protocol ID
- AKIPA
- Status last verified
- Jul 2018
- First submitted
- 1 Aug 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdulkader RC, Liborio AB, Malheiros DM. Histological features of acute tubular necrosis in native kidneys and long-term renal function. Ren Fail. 2008;30(7):667-73. doi: 10.1080/08860220802212460.
PubMed 18704814Coca SG, Singanamala S, Parikh CR. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis. Kidney Int. 2012 Mar;81(5):442-8. doi: 10.1038/ki.2011.379. Epub 2011 Nov 23.
PubMed 22113526Mathur NB, Agarwal HS, Maria A. Acute renal failure in neonatal sepsis. Indian J Pediatr. 2006 Jun;73(6):499-502. doi: 10.1007/BF02759894.
PubMed 16816511Cuzzolin L, Fanos V, Pinna B, di Marzio M, Perin M, Tramontozzi P, Tonetto P, Cataldi L. Postnatal renal function in preterm newborns: a role of diseases, drugs and therapeutic interventions. Pediatr Nephrol. 2006 Jul;21(7):931-8. doi: 10.1007/s00467-006-0118-2. Epub 2006 May 25.
PubMed 16773403Subramanian S, Agarwal R, Deorari AK, Paul VK, Bagga A. Acute renal failure in neonates. Indian J Pediatr. 2008 Apr;75(4):385-91. doi: 10.1007/s12098-008-0043-4. Epub 2008 May 18.
PubMed 18536895Bona E, Hagberg H, Loberg EM, Bagenholm R, Thoresen M. Protective effects of moderate hypothermia after neonatal hypoxia-ischemia: short- and long-term outcome. Pediatr Res. 1998 Jun;43(6):738-45. doi: 10.1203/00006450-199806000-00005.
PubMed 9621982Oncel MY, Canpolat FE, Arayici S, Alyamac Dizdar E, Uras N, Oguz SS. Urinary markers of acute kidney injury in newborns with perinatal asphyxia (.). Ren Fail. 2016 Jul;38(6):882-8. doi: 10.3109/0886022X.2016.1165070. Epub 2016 Apr 7.
PubMed 27055689Durkan AM, Alexander RT. Acute kidney injury post neonatal asphyxia. J Pediatr. 2011 Feb;158(2 Suppl):e29-33. doi: 10.1016/j.jpeds.2010.11.010.
PubMed 21238703Bagshaw SM, Bellomo R. Early diagnosis of acute kidney injury. Curr Opin Crit Care. 2007 Dec;13(6):638-44. doi: 10.1097/MCC.0b013e3282f07570.
PubMed 17975383Kandasamy Y, Smith R, Wright IM. Measuring cystatin C to determine renal function in neonates. Pediatr Crit Care Med. 2013 Mar;14(3):318-22. doi: 10.1097/PCC.0b013e318271f4a5.
PubMed 23392363Jetton JG, Askenazi DJ. Acute kidney injury in the neonate. Clin Perinatol. 2014 Sep;41(3):487-502. doi: 10.1016/j.clp.2014.05.001. Epub 2014 Jul 22.
PubMed 25155722
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Predictor of Acute Kidney Injury in Newborns With Perinatal Asphyxia
- ClinicalTrials.gov ID
- NCT03617055
- Acronym / sponsor ID
- AKIPA
- Conditions
- Acute Kidney Injury
- Keywords
- kidney injury, asphyxia,cystatin c
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the role of serum cystatin C (sCysC) as an early predictor for both diagnosis and short term outcome evaluation of acute kidney injury (AKI) in neonates with perinatal asphyxia admitted to Neonatal Intensive Care Unit (NICU) of Assiut University Children Hospital
Detailed description
Acute Kidney Injury is defined as the inability of the kidneys to excrete nitrogenous waste products and maintain fluid and electrolyte homeostasis. It is fairly common in newborn population and is a major contributor factor of neonatal mortality and morbidity.
The most common form of Acute Kidney Injury in neonates is prerenal failure due to renal hypo-perfusion or ischemia. Pre-renal failure may result in intrinsic kidney failure if it is not treated promptly. The kidneys of neonates are particularly susceptible to hypo-perfusion because of the physiologic characteristics of neonatal kidneys, including high renal vascular resistance, high plasma renin activity, low glomerular filtration, decreased intra-cortical perfusion rate and decreased reabsorption of sodium in the proximal tubules in the first days of a neonatal life. Thus, newborn infants are vulnerable to acute tubular necrosis or cortical necrosis.
The cause of Acute Kidney Injury in neonates is of multi-factorial etiology and, usually, there is one or more associated contributing factor. In most studies, perinatal asphyxia and sepsis are the most commonly associated conditions.
Perinatal asphyxia is defined as abnormal neurological incident resulting in neonatal hypoxic ischemic encephalopathy , which occurs usually due to brain hypoxia and ischemic incidents. Perinatal asphyxia can result in multi-organ dysfunction through redirection of cardiac output to maintain cerebral, cardiac, and adrenal perfusion while potentially compromising perfusion to non-vital organs including kidneys, this causing Acute Kidney Injury.
The incidence of Acute Kidney Injury after Perinatal asphyxia in term neonates was shown to be around 30% to 56%. Early detection of Acute Kidney Injury could optimize and improve patient outcomes. therefore, the use of biomarkers to predict renal damage has been of interest. Serum creatinine is the most commonly used clinical measure of renal function; however, it is a poor diagnostic marker and its utility is further questionable in neonates since kidneys undergo maturational changes in postnatal period.
Human Cystatin C is a low molecular weight protein, belonging to the cystatin superfamily of protease inhibitors, which is produced at a constant rate in all nucleated cells. Cystatin C is freely filtered through the glomerular membrane, then completely reabsorbed and degraded by the proximal tubule. Serum Cystatin C is being promoted as a more accurate estimate of neonatal glomerular filtration rate.
Acute Kidney Injury was diagnosed on the basis of changes in the serum creatinine level according to the modified neonatal Acute Kidney Injury of Kidney Disease Improving Global Outcome definition (Table 1). AKI was defined as an increase in the serum creatinine level by ≥ 0.3 mg/dL within 48 hours or ≥ 1.5 times from the baseline within 7 days.
Newborns are unique in that the serum creatinine level immediately after birth often reflects maternal levels. Studies have reported that the mean serum creatinine level in preterm infants rises during the first two days of postnatal life, reaches a plateau for a few days, and then decreases thereafter .Therefore, the baseline serum creatinine level was defined as the lowest previous serum creatinine level after 24 hours of age.
TABLE 1 Acute Kidney Injury of Kidney Disease Improving Global Outcome definition:
Stage serum creatinine Urine Output 0 No change or rise < 0.3 mg/dL. ≥ 0.5 mL/kg/h.
- rise ≥ 0.3 mg/dL within 48 h or rise ≥1.5-1.9 × reference level* within 7 days. < 0.5 mL/kg/h for 6 to 12 h.
- rise ≥ 2.0-2.9 × reference level * < 0.5 mL/kg/h for ≥ 12 h.
- rise ≥ 3 × reference level * or serum creatinine level ≥ 2.5 mg/dL or Receipt of dialysis. < 0.3 mL/kg/h for ≥ 24 h or anuria for ≥ 12 h.
- Reference level will be defined as the lowest previous serum creatinine.
The goal of Acute Kidney Injury management in newborns is to maintain homeostasis until the renal functions return, and is accomplished by addressing fluid and electrolyte imbalance, nutritional needs, and acidosis.Unfortunately, available data on the long-term outcome of neonatal Acute Kidney Injury patients is limited.
The short-term outcome of therapy for Acute Kidney Injury in newborns is dependent on the underlying etiology of Acute Kidney Injury, the involvement of other organs and the availability of renal replacement therapy. As expected, mortality is more frequent and morbidity is much worse in neonates with multi-organ failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- all full term neonates with documented perinatal asphyxiaby by one of the following indicators: (i) Presence of a sentinel hypoxic event immediately before or during delivery; (ii) History of fetal distress (bradycardia, late decelerations, absence of heart rate variability); (iii) Need for neonatal resuscitation at delivery; (iv) 1-min Apgar score <3 or 5-min Apgar score <7; or metabolic acidosis (BE > 10 in cord blood).
Key inclusion criteria (1 listed)
- all full term neonates who are admitted to neonatal intensive care unit of Assiut University Children Hospital through the period from Jan. 2019 to Jan. 2020 with documented perinatal asphyxia
Key exclusion criteria (1 listed)
- preterm neonates < 37 weeks, neonates who died within the first 24 hours of admission, neonates with any congenital anomalies like skeletal, renal or urinary tract, neonates with AKI for any cause other than asphyxia and neonates with maternal history of renal failure .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum cystatin cBlood sample for serum cystatin c will be taken on the first and third days of life for all neonates with clinical or laboratory signs of perinatal asphyxia who are admitted to NICU for early detection of AKI in the study group. | Diagnostic test | – |
Primary outcome
serum cystatin C (sCysC) as an early predictor of acute kidney injury (AKI) in neonates with perinatal asphyxia.
Time frame: one year
measuring serum cystatin c in neonates with perinatal asphyxia
1 secondary outcome
is to determine the incidence of Acute kidney injury in neonates with perinatal asphyxia.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Background: PubMed 18704814Abdulkader RC, Liborio AB, Malheiros DM. Histological features of acute tubular necrosis in native kidneys and long-term renal function. Ren Fail. 2008;30(7):667-73. doi: 10.1080/08860220802212460.
- Background: PubMed 22113526Coca SG, Singanamala S, Parikh CR. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis. Kidney Int. 2012 Mar;81(5):442-8. doi: 10.1038/ki.2011.379. Epub 2011 Nov 23.
- Background: PubMed 16816511Mathur NB, Agarwal HS, Maria A. Acute renal failure in neonatal sepsis. Indian J Pediatr. 2006 Jun;73(6):499-502. doi: 10.1007/BF02759894.
- Background: PubMed 16773403Cuzzolin L, Fanos V, Pinna B, di Marzio M, Perin M, Tramontozzi P, Tonetto P, Cataldi L. Postnatal renal function in preterm newborns: a role of diseases, drugs and therapeutic interventions. Pediatr Nephrol. 2006 Jul;21(7):931-8. doi: 10.1007/s00467-006-0118-2. Epub 2006 May 25.
- Background: PubMed 18536895Subramanian S, Agarwal R, Deorari AK, Paul VK, Bagga A. Acute renal failure in neonates. Indian J Pediatr. 2008 Apr;75(4):385-91. doi: 10.1007/s12098-008-0043-4. Epub 2008 May 18.
- Background: PubMed 9621982Bona E, Hagberg H, Loberg EM, Bagenholm R, Thoresen M. Protective effects of moderate hypothermia after neonatal hypoxia-ischemia: short- and long-term outcome. Pediatr Res. 1998 Jun;43(6):738-45. doi: 10.1203/00006450-199806000-00005.
- Background: PubMed 27055689Oncel MY, Canpolat FE, Arayici S, Alyamac Dizdar E, Uras N, Oguz SS. Urinary markers of acute kidney injury in newborns with perinatal asphyxia (.). Ren Fail. 2016 Jul;38(6):882-8. doi: 10.3109/0886022X.2016.1165070. Epub 2016 Apr 7.
- Background: PubMed 21238703Durkan AM, Alexander RT. Acute kidney injury post neonatal asphyxia. J Pediatr. 2011 Feb;158(2 Suppl):e29-33. doi: 10.1016/j.jpeds.2010.11.010.
- Background: PubMed 17975383Bagshaw SM, Bellomo R. Early diagnosis of acute kidney injury. Curr Opin Crit Care. 2007 Dec;13(6):638-44. doi: 10.1097/MCC.0b013e3282f07570.
- Background: PubMed 23392363Kandasamy Y, Smith R, Wright IM. Measuring cystatin C to determine renal function in neonates. Pediatr Crit Care Med. 2013 Mar;14(3):318-22. doi: 10.1097/PCC.0b013e318271f4a5.
- Background: PubMed 25155722Jetton JG, Askenazi DJ. Acute kidney injury in the neonate. Clin Perinatol. 2014 Sep;41(3):487-502. doi: 10.1016/j.clp.2014.05.001. Epub 2014 Jul 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nafesa refaat, MD (00201148336224, nrefat@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum cystatin C (sCysC) as an early predictor of acute kidney injury (AKI) in neonates with perinatal asphyxia. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03617055, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.