Acute Kidney InjuryAWAKENNCT02443389
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates
An observational study of Acute Kidney Injury, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Introduction: Based on single-center data, approximately 1 of every 3 newborns admitted to tertiary level neonatal intensive care units (NICU) develops acute kidney injury (AKI), and those with AKI have significantly worse outcomes. Read more about this study
- Who is it for?
- Ages 1 minute to 2 weeks
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 2,186 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Mar 2016
- How long will I take part?
- 120 Days
- 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 minute to 2 weeks
- All sexes
- No healthy volunteers
- Child
Study population: The investigators will conduct a multi-center retrospective cohort study. The investigators will enroll eligible infants who meet inclusion and exclusion criteria at each center for 3 consecutive months. Based on average admissions for 2013 at our centers who meet inclusion and exclusion criteria, it is estimated that it can enroll approximately 3000 infants during this time. All infants admitted to the NICU between January 1, 2014 and march 31, 2014 will be screened for the study.
Who may be able to join
- All infants born or admitted to a level 2 or 3 NICU will be screened.
- Infants who received intravenous fluids for > 48 hours will be eligible.
Who cannot join
- Infants admitted to the NICU at 2 weeks of age or older
- Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life
- Infants diagnosed with a lethal anomaly upon admission
- Infants who die within 48 hours after birth
Trial locations and contacts
1 site in 1 country.
About this study
Introduction:
Based on single-center data, approximately 1 of every 3 newborns admitted to tertiary level neonatal intensive care units (NICU) develops acute kidney injury (AKI), and those with AKI have significantly worse outcomes. To stimulate discussion among researchers, the NIH NIDDK sponsored a workshop on neonatal AKI in April 2013. At that workshop, the group recognized the need to improve collaborations between neonatologists and nephrologists within and across centers. The investigators have created a multi-institutional, multi-disciplinary group, Neonatal Kidney Collaborative (NKC), in order to address the following critical needs identified at the workshop: AWAKEN is the inaugural study of this new collaboration.
- Development of a standardized evidence-based definition of neonatal AKI
- Evaluation of risk factors that predispose neonatal to AKI
- Investigation into how fluid provision/ balance impacts biochemical and clinical outcomes
Read the detailed description
The investigators will conduct a multi-center retrospective cohort study. The investigators will enroll eligible infants who meet inclusion and exclusion criteria at each center for 3 consecutive months. Based on average admissions for 2013 at our centers who meet inclusion and exclusion criteria, and estimate that it can enroll approximately 3000 infants during this time.
- Specific Aim 1: Determine if the proposed neonatal AKI definition adapted to neonates is able to predict mortality, length of stay, and discharge serum creatinine (SCr).
- Our primary hypothesis is that higher stages of AKI are associated with mortality, even after controlling for severity of illness, interventions and demographics.
- Populations
- Inclusion Criteria - All infants born or admitted to a level 2 or 3 NICU will be screened. Infants who received intravenous fluids for > 48 hours will be eligible.
- Exclusion -- Infants admitted to the NICU at 2 weeks of age or older; Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life; Infants diagnosed with a lethal anomaly upon admission; Infants who die within 48 hours after birth
- Primary Exposure - Neonatal AKI definitions (table 3)
- Primary Outcome - Survival
- In premature infants - defined as survival to 36 weeks post gestational age or hospital discharge (whichever comes first)
- In term infants - defined as hospital survival to 28 days.
- Secondary outcomes
- Hospital length of stay
- Last serum creatinine obtained
- Potential confounders - gestational age, birth weight, 5 minute APGAR score, multiple gestation, significant renal anomalies, SNAP-II score
- Exploratory outcomes - recognize that the proposed definition may not be the best definition to predict clinical outcomes. Also recognize that there may be a need to have different definitions for premature infants. The investigators plan to explore how other definitions reported in the literature can predict these outcomes (for example using the 90th % for normative values). In addition, this will have the largest comprehensive database to explore new definitions which could incorporate urine output, fluid balance and other factors.
- Specific Aim 2: Define the risk factors associated with neonatal AKI.
- Our hypothesis is that maternal and infant risk factors will predict AKI.
- Population - same as in Specific Aim 1
- Design - randomize cohort to a prediction and a validation groups. Develop a risk factor prediction model with the first group, and test the ability of the model to predict AKI with the second group.
- Exposures (see full list in appendix 1 - Data collection sheets)
- Maternal Demographic Factors
- Neonatal Demographic Factors
- Interventions / Medications
- Co-Morbidities
- Primary Outcome - KDIGO AKI definition modified for neonates (Table 3).
- Specific Aim 3: Determine how fluid balance during the first few weeks of life relates to biochemical data and clinical outcomes.
- Our hypotheses are that fluid provision affects chemistry panels (serum creatinine, blood urea nitrogen, serum sodium) and that fluid balance is associated with clinical outcomes.
- Population - same as in Specific Aim 1
- Design
- Evaluation of fluid balance - will use birth weight as the reference weight and calculate changes in weight over time as a percentage of birth weight.
- Will describe the association between fluid balance and changes in serum creatinine (SCr), blood urea nitrogen (BUN) and serum sodium.
- Will then evaluate how fluid balance (and the associated biochemical changes) affects clinical outcomes.
- Primary Clinical Outcome - Survival
- In premature infants - defined as survival to 36 weeks post gestational age or hospital discharge (whichever comes first)
- In term infants - defined as hospital survival to 28 days.
- Secondary outcomes
- Hospital length of stay
- Ventilator free days in the first 28 days of life.
- Bronchopulmonary dysplasia
- Intraventricular hemorrhage
- Last serum creatinine obtained
- Use of blood pressure support medications
- Use of diuretics
- Patent ductus arteriosus
Data will be captured at each institution and entered into web-based forms in real time.
The investigators plan to have 5 different integrated forms:
- Screening form
- Baseline form for included infants
- Daily Assessment form (first 7 days after birth)
- Weekly Assessment form (weeks 2 - 18)
- Discharge form
- Conditions
- Acute Kidney Injury
- Keywords
- nephrotoxic, Fluid overload, Acute renal failure, Prematurity, Risk factors, Epidemiology
- Medical subject headings
- Acute Kidney Injury, Edema, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neonates admitted to NICU | Retrospective cohort of neonates admitted to NICU with stated inclusion and exclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if the KDIGO AKI definition adapted to neonates can predict mortality, length of stay, and discharge serum creatinine (SCr).
Measured: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.
Define the major risk factors associated with neonatal AKI. We will randomly split the cohort into two groups. We will develop a risk factor prediction model with the first group, and test the ability of the model to predict AKI with the second group.
Measured: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.
Determine how fluid balance during the first few weeks of life relates to biochemical data and clinical outcomes.
Measured: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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 University of Alabama at BirminghamThe 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
- Other
- Enrolment
- 2,186 participants (actual)
- Target duration
- 120 Days
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, George Washington University, McGill University, Albert Einstein College of Medicine, University of Rochester, University of British Columbia, University of Iowa, University of Michigan, University of New Mexico, University of Virginia, University of Washington, University of Miami, Case Western Reserve University, University of Kentucky, Maimonides Medical Center, Stony Brook University, The Canberra Hospital, Children's Hospital Colorado, St. Louis Children's Hospital, Baylor College of Medicine, Medanta, The Medicity, India, Ohio State University
- Responsible party
- Principal investigator, David Askenazi, University of Alabama at Birmingham
- Investigators
- David Askenazi, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443389
- Sponsor's protocol ID
- X140917002
- Acronym
- AWAKEN
- Status last verified
- Dec 2022
- First submitted
- 11 May 2015
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Selewski DT, Gist KM, Nathan AT, Goldstein SL, Boohaker LJ, Akcan-Arikan A, Bonachea EM, Hanna M, Joseph C, Mahan JD, Mammen C, Nada A, Reidy K, Staples A, Wintermark P, Griffin R, Askenazi DJ, Guillet R; Neonatal Kidney Collaborative. The impact of fluid balance on outcomes in premature neonates: a report from the AWAKEN study group. Pediatr Res. 2020 Feb;87(3):550-557. doi: 10.1038/s41390-019-0579-1. Epub 2019 Sep 19.
PubMed 31537009Starr MC, Boohaker L, Eldredge LC, Menon S, Griffin R, Mayock D, Askenazi D, Hingorani S; Neonatal Kidney Collaborative. Acute Kidney Injury is Associated with Poor Lung Outcomes in Infants Born >/=32 Weeks of Gestational Age. Am J Perinatol. 2020 Jan;37(2):231-240. doi: 10.1055/s-0039-1698836. Epub 2019 Nov 18.
PubMed 31739364Askenazi D, Abitbol C, Boohaker L, Griffin R, Raina R, Dower J, Davis TK, Ray PE, Perazzo S, DeFreitas M, Milner L, Ambalavanan N, Cole FS, Rademacher E, Zappitelli M, Mhanna M; Neonatal Kidney Collaborative. Optimizing the AKI definition during first postnatal week using Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates (AWAKEN) cohort. Pediatr Res. 2019 Feb;85(3):329-338. doi: 10.1038/s41390-018-0249-8. Epub 2018 Dec 13.
PubMed 30643188Charlton JR, Boohaker L, Askenazi D, Brophy PD, D'Angio C, Fuloria M, Gien J, Griffin R, Hingorani S, Ingraham S, Mian A, Ohls RK, Rastogi S, Rhee CJ, Revenis M, Sarkar S, Smith A, Starr M, Kent AL; Neonatal Kidney Collaborative. Incidence and Risk Factors of Early Onset Neonatal AKI. Clin J Am Soc Nephrol. 2019 Feb 7;14(2):184-195. doi: 10.2215/CJN.03670318. Epub 2019 Jan 31.
PubMed 31738181Harer MW, Askenazi DJ, Boohaker LJ, Carmody JB, Griffin RL, Guillet R, Selewski DT, Swanson JR, Charlton JR; Neonatal Kidney Collaborative (NKC). Association Between Early Caffeine Citrate Administration and Risk of Acute Kidney Injury in Preterm Neonates: Results From the AWAKEN Study. JAMA Pediatr. 2018 Jun 4;172(6):e180322. doi: 10.1001/jamapediatrics.2018.0322. Epub 2018 Jun 4.
PubMed 29610830Kraut EJ, Boohaker LJ, Askenazi DJ, Fletcher J, Kent AL; Neonatal Kidney Collaborative (NKC). Incidence of neonatal hypertension from a large multicenter study [Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates-AWAKEN]. Pediatr Res. 2018 Aug;84(2):279-289. doi: 10.1038/s41390-018-0018-8. Epub 2018 May 23.
PubMed 29795211Jetton JG, Boohaker LJ, Sethi SK, Wazir S, Rohatgi S, Soranno DE, Chishti AS, Woroniecki R, Mammen C, Swanson JR, Sridhar S, Wong CS, Kupferman JC, Griffin RL, Askenazi DJ; Neonatal Kidney Collaborative (NKC). Incidence and outcomes of neonatal acute kidney injury (AWAKEN): a multicentre, multinational, observational cohort study. Lancet Child Adolesc Health. 2017 Nov;1(3):184-194. doi: 10.1016/S2352-4642(17)30069-X.
PubMed 29732396Selewski DT, Akcan-Arikan A, Bonachea EM, Gist KM, Goldstein SL, Hanna M, Joseph C, Mahan JD, Nada A, Nathan AT, Reidy K, Staples A, Wintermark P, Boohaker LJ, Griffin R, Askenazi DJ, Guillet R; Neonatal Kidney Collaborative. The impact of fluid balance on outcomes in critically ill near-term/term neonates: a report from the AWAKEN study group. Pediatr Res. 2019 Jan;85(1):79-85. doi: 10.1038/s41390-018-0183-9. Epub 2018 Sep 20.
PubMed 30237572Kirkley MJ, Boohaker L, Griffin R, Soranno DE, Gien J, Askenazi D, Gist KM; Neonatal Kidney Collaborative (NKC). Acute kidney injury in neonatal encephalopathy: an evaluation of the AWAKEN database. Pediatr Nephrol. 2019 Jan;34(1):169-176. doi: 10.1007/s00467-018-4068-2. Epub 2018 Aug 28.
PubMed 30155763Charlton JR, Boohaker L, Askenazi D, Brophy PD, Fuloria M, Gien J, Griffin R, Hingorani S, Ingraham S, Mian A, Ohls RK, Rastogi S, Rhee CJ, Revenis M, Sarkar S, Starr M, Kent AL; Neonatal Kidney Collaborative (NKC). Late onset neonatal acute kidney injury: results from the AWAKEN Study. Pediatr Res. 2019 Feb;85(3):339-348. doi: 10.1038/s41390-018-0255-x. Epub 2018 Dec 13.
PubMed 30546043Jetton JG, Guillet R, Askenazi DJ, Dill L, Jacobs J, Kent AL, Selewski DT, Abitbol CL, Kaskel FJ, Mhanna MJ, Ambalavanan N, Charlton JR; Neonatal Kidney Collaborative. Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates: Design of a Retrospective Cohort Study. Front Pediatr. 2016 Jul 19;4:68. doi: 10.3389/fped.2016.00068. eCollection 2016.
PubMed 27486571Kent AL, Charlton JR, Guillet R, Gist KM, Hanna M, El Samra A, Fletcher J, Selewski DT, Mammen C. Neonatal Acute Kidney Injury: A Survey of Neonatologists' and Nephrologists' Perceptions and Practice Management. Am J Perinatol. 2018 Jan;35(1):1-9. doi: 10.1055/s-0037-1604260. Epub 2017 Jul 14.
PubMed 28709164Stoops C, Boohaker L, Sims B, Griffin R, Selewski DT, Askenazi D; on behalf of the National Kidney Collaborative (NKC). The Association of Intraventricular Hemorrhage and Acute Kidney Injury in Premature Infants from the Assessment of the Worldwide Acute Kidney Injury Epidemiology in Neonates (AWAKEN) Study. Neonatology. 2019;116(4):321-330. doi: 10.1159/000501708. Epub 2019 Aug 28.
PubMed 31461717
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates
- ClinicalTrials.gov ID
- NCT02443389
- Acronym / sponsor ID
- AWAKEN / X140917002
- Conditions
- Acute Kidney Injury
- Keywords
- nephrotoxic, Fluid overload, Acute renal failure, Prematurity, Risk factors, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,186 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, George Washington University, McGill University, Albert Einstein College of Medicine, University of Rochester, University of British Columbia, University of Iowa, University of Michigan, University of New Mexico, University of Virginia, University of Washington, University of Miami, Case Western Reserve University, University of Kentucky, Maimonides Medical Center, Stony Brook University, The Canberra Hospital, Children's Hospital Colorado, St. Louis Children's Hospital, Baylor College of Medicine, Medanta, The Medicity, India, Ohio State University
- Study start
- Mar 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 May 2015 (estimated)
- 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.
Introduction:
Based on single-center data, approximately 1 of every 3 newborns admitted to tertiary level neonatal intensive care units (NICU) develops acute kidney injury (AKI), and those with AKI have significantly worse outcomes. To stimulate discussion among researchers, the NIH NIDDK sponsored a workshop on neonatal AKI in April 2013. At that workshop, the group recognized the need to improve collaborations between neonatologists and nephrologists within and across centers. The investigators have created a multi-institutional, multi-disciplinary group, Neonatal Kidney Collaborative (NKC), in order to address the following critical needs identified at the workshop: AWAKEN is the inaugural study of this new collaboration.
- Development of a standardized evidence-based definition of neonatal AKI
- Evaluation of risk factors that predispose neonatal to AKI
- Investigation into how fluid provision/ balance impacts biochemical and clinical outcomes
Detailed description
The investigators will conduct a multi-center retrospective cohort study. The investigators will enroll eligible infants who meet inclusion and exclusion criteria at each center for 3 consecutive months. Based on average admissions for 2013 at our centers who meet inclusion and exclusion criteria, and estimate that it can enroll approximately 3000 infants during this time.
- Specific Aim 1: Determine if the proposed neonatal AKI definition adapted to neonates is able to predict mortality, length of stay, and discharge serum creatinine (SCr).
- Our primary hypothesis is that higher stages of AKI are associated with mortality, even after controlling for severity of illness, interventions and demographics.
- Populations
- Inclusion Criteria - All infants born or admitted to a level 2 or 3 NICU will be screened. Infants who received intravenous fluids for > 48 hours will be eligible.
- Exclusion -- Infants admitted to the NICU at 2 weeks of age or older; Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life; Infants diagnosed with a lethal anomaly upon admission; Infants who die within 48 hours after birth
- Primary Exposure - Neonatal AKI definitions (table 3)
- Primary Outcome - Survival
- In premature infants - defined as survival to 36 weeks post gestational age or hospital discharge (whichever comes first)
- In term infants - defined as hospital survival to 28 days.
- Secondary outcomes
- Hospital length of stay
- Last serum creatinine obtained
- Potential confounders - gestational age, birth weight, 5 minute APGAR score, multiple gestation, significant renal anomalies, SNAP-II score
- Exploratory outcomes - recognize that the proposed definition may not be the best definition to predict clinical outcomes. Also recognize that there may be a need to have different definitions for premature infants. The investigators plan to explore how other definitions reported in the literature can predict these outcomes (for example using the 90th % for normative values). In addition, this will have the largest comprehensive database to explore new definitions which could incorporate urine output, fluid balance and other factors.
- Specific Aim 2: Define the risk factors associated with neonatal AKI.
- Our hypothesis is that maternal and infant risk factors will predict AKI.
- Population - same as in Specific Aim 1
- Design - randomize cohort to a prediction and a validation groups. Develop a risk factor prediction model with the first group, and test the ability of the model to predict AKI with the second group.
- Exposures (see full list in appendix 1 - Data collection sheets)
- Maternal Demographic Factors
- Neonatal Demographic Factors
- Interventions / Medications
- Co-Morbidities
- Primary Outcome - KDIGO AKI definition modified for neonates (Table 3).
- Specific Aim 3: Determine how fluid balance during the first few weeks of life relates to biochemical data and clinical outcomes.
- Our hypotheses are that fluid provision affects chemistry panels (serum creatinine, blood urea nitrogen, serum sodium) and that fluid balance is associated with clinical outcomes.
- Population - same as in Specific Aim 1
- Design
- Evaluation of fluid balance - will use birth weight as the reference weight and calculate changes in weight over time as a percentage of birth weight.
- Will describe the association between fluid balance and changes in serum creatinine (SCr), blood urea nitrogen (BUN) and serum sodium.
- Will then evaluate how fluid balance (and the associated biochemical changes) affects clinical outcomes.
- Primary Clinical Outcome - Survival
- In premature infants - defined as survival to 36 weeks post gestational age or hospital discharge (whichever comes first)
- In term infants - defined as hospital survival to 28 days.
- Secondary outcomes
- Hospital length of stay
- Ventilator free days in the first 28 days of life.
- Bronchopulmonary dysplasia
- Intraventricular hemorrhage
- Last serum creatinine obtained
- Use of blood pressure support medications
- Use of diuretics
- Patent ductus arteriosus
Data will be captured at each institution and entered into web-based forms in real time.
The investigators plan to have 5 different integrated forms:
- Screening form
- Baseline form for included infants
- Daily Assessment form (first 7 days after birth)
- Weekly Assessment form (weeks 2 - 18)
- Discharge form
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 120 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates admitted to NICU | – | –Retrospective cohort of neonates admitted to NICU with stated inclusion and exclusion criteria |
Who may qualify
- Ages
- 1 minute to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The investigators will conduct a multi-center retrospective cohort study. The investigators will enroll eligible infants who meet inclusion and exclusion criteria at each center for 3 consecutive months. Based on average admissions for 2013 at our centers who meet inclusion and exclusion criteria, it is estimated that it can enroll approximately 3000 infants during this time. All infants admitted to the NICU between January 1, 2014 and march 31, 2014 will be screened for the study.
Key inclusion criteria (2 listed)
- All infants born or admitted to a level 2 or 3 NICU will be screened.
- Infants who received intravenous fluids for > 48 hours will be eligible.
Key exclusion criteria (4 listed)
- Infants admitted to the NICU at 2 weeks of age or older
- Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life
- Infants diagnosed with a lethal anomaly upon admission
- Infants who die within 48 hours after birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine if the KDIGO AKI definition adapted to neonates can predict mortality, length of stay, and discharge serum creatinine (SCr).
Time frame: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.
Define the major risk factors associated with neonatal AKI. We will randomly split the cohort into two groups. We will develop a risk factor prediction model with the first group, and test the ability of the model to predict AKI with the second group.
Time frame: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.
Determine how fluid balance during the first few weeks of life relates to biochemical data and clinical outcomes.
Time frame: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Background: PubMed 31537009Selewski DT, Gist KM, Nathan AT, Goldstein SL, Boohaker LJ, Akcan-Arikan A, Bonachea EM, Hanna M, Joseph C, Mahan JD, Mammen C, Nada A, Reidy K, Staples A, Wintermark P, Griffin R, Askenazi DJ, Guillet R; Neonatal Kidney Collaborative. The impact of fluid balance on outcomes in premature neonates: a report from the AWAKEN study group. Pediatr Res. 2020 Feb;87(3):550-557. doi: 10.1038/s41390-019-0579-1. Epub 2019 Sep 19.
- Background: PubMed 31739364Starr MC, Boohaker L, Eldredge LC, Menon S, Griffin R, Mayock D, Askenazi D, Hingorani S; Neonatal Kidney Collaborative. Acute Kidney Injury is Associated with Poor Lung Outcomes in Infants Born >/=32 Weeks of Gestational Age. Am J Perinatol. 2020 Jan;37(2):231-240. doi: 10.1055/s-0039-1698836. Epub 2019 Nov 18.
- Background: PubMed 30643188Askenazi D, Abitbol C, Boohaker L, Griffin R, Raina R, Dower J, Davis TK, Ray PE, Perazzo S, DeFreitas M, Milner L, Ambalavanan N, Cole FS, Rademacher E, Zappitelli M, Mhanna M; Neonatal Kidney Collaborative. Optimizing the AKI definition during first postnatal week using Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates (AWAKEN) cohort. Pediatr Res. 2019 Feb;85(3):329-338. doi: 10.1038/s41390-018-0249-8. Epub 2018 Dec 13.
- Background: PubMed 31738181Charlton JR, Boohaker L, Askenazi D, Brophy PD, D'Angio C, Fuloria M, Gien J, Griffin R, Hingorani S, Ingraham S, Mian A, Ohls RK, Rastogi S, Rhee CJ, Revenis M, Sarkar S, Smith A, Starr M, Kent AL; Neonatal Kidney Collaborative. Incidence and Risk Factors of Early Onset Neonatal AKI. Clin J Am Soc Nephrol. 2019 Feb 7;14(2):184-195. doi: 10.2215/CJN.03670318. Epub 2019 Jan 31.
- Background: PubMed 29610830Harer MW, Askenazi DJ, Boohaker LJ, Carmody JB, Griffin RL, Guillet R, Selewski DT, Swanson JR, Charlton JR; Neonatal Kidney Collaborative (NKC). Association Between Early Caffeine Citrate Administration and Risk of Acute Kidney Injury in Preterm Neonates: Results From the AWAKEN Study. JAMA Pediatr. 2018 Jun 4;172(6):e180322. doi: 10.1001/jamapediatrics.2018.0322. Epub 2018 Jun 4.
- Background: PubMed 29795211Kraut EJ, Boohaker LJ, Askenazi DJ, Fletcher J, Kent AL; Neonatal Kidney Collaborative (NKC). Incidence of neonatal hypertension from a large multicenter study [Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates-AWAKEN]. Pediatr Res. 2018 Aug;84(2):279-289. doi: 10.1038/s41390-018-0018-8. Epub 2018 May 23.
- Background: PubMed 29732396Jetton JG, Boohaker LJ, Sethi SK, Wazir S, Rohatgi S, Soranno DE, Chishti AS, Woroniecki R, Mammen C, Swanson JR, Sridhar S, Wong CS, Kupferman JC, Griffin RL, Askenazi DJ; Neonatal Kidney Collaborative (NKC). Incidence and outcomes of neonatal acute kidney injury (AWAKEN): a multicentre, multinational, observational cohort study. Lancet Child Adolesc Health. 2017 Nov;1(3):184-194. doi: 10.1016/S2352-4642(17)30069-X.
- Background: PubMed 30237572Selewski DT, Akcan-Arikan A, Bonachea EM, Gist KM, Goldstein SL, Hanna M, Joseph C, Mahan JD, Nada A, Nathan AT, Reidy K, Staples A, Wintermark P, Boohaker LJ, Griffin R, Askenazi DJ, Guillet R; Neonatal Kidney Collaborative. The impact of fluid balance on outcomes in critically ill near-term/term neonates: a report from the AWAKEN study group. Pediatr Res. 2019 Jan;85(1):79-85. doi: 10.1038/s41390-018-0183-9. Epub 2018 Sep 20.
- Background: PubMed 30155763Kirkley MJ, Boohaker L, Griffin R, Soranno DE, Gien J, Askenazi D, Gist KM; Neonatal Kidney Collaborative (NKC). Acute kidney injury in neonatal encephalopathy: an evaluation of the AWAKEN database. Pediatr Nephrol. 2019 Jan;34(1):169-176. doi: 10.1007/s00467-018-4068-2. Epub 2018 Aug 28.
- Background: PubMed 30546043Charlton JR, Boohaker L, Askenazi D, Brophy PD, Fuloria M, Gien J, Griffin R, Hingorani S, Ingraham S, Mian A, Ohls RK, Rastogi S, Rhee CJ, Revenis M, Sarkar S, Starr M, Kent AL; Neonatal Kidney Collaborative (NKC). Late onset neonatal acute kidney injury: results from the AWAKEN Study. Pediatr Res. 2019 Feb;85(3):339-348. doi: 10.1038/s41390-018-0255-x. Epub 2018 Dec 13.
- Background: PubMed 27486571Jetton JG, Guillet R, Askenazi DJ, Dill L, Jacobs J, Kent AL, Selewski DT, Abitbol CL, Kaskel FJ, Mhanna MJ, Ambalavanan N, Charlton JR; Neonatal Kidney Collaborative. Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates: Design of a Retrospective Cohort Study. Front Pediatr. 2016 Jul 19;4:68. doi: 10.3389/fped.2016.00068. eCollection 2016.
- Background: PubMed 28709164Kent AL, Charlton JR, Guillet R, Gist KM, Hanna M, El Samra A, Fletcher J, Selewski DT, Mammen C. Neonatal Acute Kidney Injury: A Survey of Neonatologists' and Nephrologists' Perceptions and Practice Management. Am J Perinatol. 2018 Jan;35(1):1-9. doi: 10.1055/s-0037-1604260. Epub 2017 Jul 14.
- Individual participant dataSharing planned: No
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Acute-on-Chronic Liver Failure (ACLF)
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
David Askenazi, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University of Alabama at Birmingham at 1 site in United States.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if the KDIGO AKI definition adapted to neonates can predict mortality, length of stay, and discharge serum creatinine (SCr). (time frame: NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.). The study lists 3 primary outcomes in all. 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 NCT02443389, which also lists 13 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 15 Dec 2022.