Acute Kidney InjuryNCT02553174
AKI in Thoracic and Abdominal Surgery
An observational study of Acute Kidney Injury, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The study will investigate the role of NSAIDs in the development of AKI in patients undergoing high-risk abdominal or thoracic surgery. The investigators hypothesize that the use of new urinary biomarkers will allow earlier detection of AKI than the current gold standard, i.e. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 23 Mar 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be identified by surgeon and by length of procedure. Patients presenting to the Anesthesia Preoperative Clinic who are scheduled to have surgery lasting longer than 4 hours by certain surgeons, and who are anticipated to recover postoperatively in the Surgical Intensive Care Unit will be given a recruitment/consent form explaining the study. The study will then be explained to potential patients by a member of the research team to determine recruitment eligibility and willingness to participate.
Who may be able to join
- age ≥ 21 (per manufacturer's instructions on the Nephrocheck kit)
- history of hypertension, whether medically treated or untreated
- scheduled for Anesthesia preoperative clinic visit
- scheduled to undergo prolonged intra-abdominal or intra-thoracic surgeries (defined as scheduled intraoperative time ≥ 4h). Intra-abdominal surgeries will include colorectal surgery, massive ventral hernia repairs, hepatobiliary surgery and gynecologic-oncology surgery. Intra-thoracic surgeries will include video-assisted thoracoscopic surgery (VATS)-assisted segmentectomy and lobectomies, as well as mediastinal mass excisions.
- will be anticipated to be admitted to the ICU for a minimum of 2-3 days post-operatively
Who cannot join
- history of chronic kidney as defined by estimated glomerular filtration rate (GFR) <90
- patient taking NSAIDs on a daily basis
- patients with a reported allergy or intolerance to NSAIDs
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Acute Kidney Injury and Nonsteroidal Anti-inflammatory Drugs in Patients Undergoing High-risk Abdominal or Thoracic Surgery
The study will investigate the role of NSAIDs in the development of AKI in patients undergoing high-risk abdominal or thoracic surgery. The investigators hypothesize that the use of new urinary biomarkers will allow earlier detection of AKI than the current gold standard, i.e. changes in serum creatinine and/or urine output.
Read the detailed description
This study will be designed as a prospective observational trial. After obtaining Institutional Review Board (IRB) approval, patients will be recruited and consented from the Anesthesia Pre-Operative Clinic. On the day of surgery, baseline urine samples will be obtained at the initial insertion of the Foley catheter, after induction of anesthesia. Urine samples will also be collected from the Foley catheter in the immediate post-operative period shortly after the patient is admitted to the Intensive Care Unit (ICU). Urine samples will continue to be collected for 72 hours post-operatively, at 0600 (6am) and 1800 (6pm) each day from the indwelling Foley catheter, which is standard of care in the ICU. Urine samples will be labeled and stored as per the instructions provided in a commercially available kit; six urine samples total will be collected and stored per patient. The electronic medical record (EMR) will be reviewed to determine whether the patient received ketorolac, ibuprofen, or no NSAIDs intra-operatively and postoperatively (within 72 hours of the beginning of surgery). Daily serum creatinine measurements and hourly urine output, which are standards of care in the ICU, will be obtained from the EMR as well.
AKI will be diagnosed and staged according to KDIGO criteria, which are based on changes in creatinine and urine output. In all patients with "KDIGO-diagnosed AKI" and in a matched non-AKI group, we will also compare the time course of new urinary biomarkers, including but not limited to uNGAL, to that of serum creatinine and urine output. We will match patients according to their demographics as well as clinical characteristics, including co-morbidities, type of surgery and anesthesia technique. Comparing the time course of current clinical markers (serum creatinine and urine output) with that of new urinary biomarkers will allow us to assess their role in guiding future preventive interventions.
- Conditions
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
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 |
|---|---|---|
| Ketorolac | Patients who receive ketorolac perioperatively | |
| Caldolor | Patients who receive Caldolor perioperatively | |
| No NSAIDS | Patients who do not receive NSAIDS perioperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
AKI defined by change in serum creatinine from baseline and change in urine output (KDIGO criteria)
Measured: 72 hours post-operatively
Secondary outcomes (1)
Urine biomarkers in AKI detection
Our secondary analysis will investigate the performance of new FDA approved urine biomarkers including, but not limited to, uNGAL (urinary neutrophil gelatinase associated lipocalin) in AKI detection.
Measured: 72 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study start1 Jun 2016
- Primary completion23 Mar 2018
- Study completion23 Mar 2018
Why it stopped: unable to recruit sufficient patients to satisfy study protocols
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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 Milton S. Hershey Medical CenterThe 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 (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Bonavia, Milton S. Hershey Medical Center
- Investigators
- Anthony Bonavia, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553174
- Sponsor's protocol ID
- STUDY00003086
- Status last verified
- Mar 2018
- First submitted
- 15 Sep 2015
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Calvert S, Shaw A. Perioperative acute kidney injury. Perioper Med (Lond). 2012 Jul 4;1:6. doi: 10.1186/2047-0525-1-6. eCollection 2012.
PubMed 24764522Singbartl K, Kellum JA. AKI in the ICU: definition, epidemiology, risk stratification, and outcomes. Kidney Int. 2012 May;81(9):819-25. doi: 10.1038/ki.2011.339. Epub 2011 Oct 5.
PubMed 21975865Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.
PubMed 23394211Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.
PubMed 15312219Luo X, Jiang L, Du B, Wen Y, Wang M, Xi X; Beijing Acute Kidney Injury Trial (BAKIT) workgroup. A comparison of different diagnostic criteria of acute kidney injury in critically ill patients. Crit Care. 2014 Jul 8;18(4):R144. doi: 10.1186/cc13977.
PubMed 25005361Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.
PubMed 23388612Witzgall R, Brown D, Schwarz C, Bonventre JV. Localization of proliferating cell nuclear antigen, vimentin, c-Fos, and clusterin in the postischemic kidney. Evidence for a heterogenous genetic response among nephron segments, and a large pool of mitotically active and dedifferentiated cells. J Clin Invest. 1994 May;93(5):2175-88. doi: 10.1172/JCI117214.
PubMed 7910173Yang QH, Liu DW, Long Y, Liu HZ, Chai WZ, Wang XT. Acute renal failure during sepsis: potential role of cell cycle regulation. J Infect. 2009 Jun;58(6):459-64. doi: 10.1016/j.jinf.2009.04.003. Epub 2009 Apr 17.
PubMed 19428114Devarajan P. Update on mechanisms of ischemic acute kidney injury. J Am Soc Nephrol. 2006 Jun;17(6):1503-20. doi: 10.1681/ASN.2006010017. Epub 2006 May 17. No abstract available.
PubMed 16707563Rodier F, Campisi J, Bhaumik D. Two faces of p53: aging and tumor suppression. Nucleic Acids Res. 2007;35(22):7475-84. doi: 10.1093/nar/gkm744. Epub 2007 Oct 16.
PubMed 17942417Boonstra J, Post JA. Molecular events associated with reactive oxygen species and cell cycle progression in mammalian cells. Gene. 2004 Aug 4;337:1-13. doi: 10.1016/j.gene.2004.04.032.
PubMed 15276197Meersch M, Schmidt C, Van Aken H, Martens S, Rossaint J, Singbartl K, Gorlich D, Kellum JA, Zarbock A. Urinary TIMP-2 and IGFBP7 as early biomarkers of acute kidney injury and renal recovery following cardiac surgery. PLoS One. 2014 Mar 27;9(3):e93460. doi: 10.1371/journal.pone.0093460. eCollection 2014.
PubMed 24675717Gocze I, Koch M, Renner P, Zeman F, Graf BM, Dahlke MH, Nerlich M, Schlitt HJ, Kellum JA, Bein T. Urinary biomarkers TIMP-2 and IGFBP7 early predict acute kidney injury after major surgery. PLoS One. 2015 Mar 23;10(3):e0120863. doi: 10.1371/journal.pone.0120863. eCollection 2015.
PubMed 25798585Lafrance JP, Miller DR. Selective and non-selective non-steroidal anti-inflammatory drugs and the risk of acute kidney injury. Pharmacoepidemiol Drug Saf. 2009 Oct;18(10):923-31. doi: 10.1002/pds.1798.
PubMed 19585463Zipser RD, Hoefs JC, Speckart PF, Zia PK, Horton R. Prostaglandins: modulators of renal function and pressor resistance in chronic liver disease. J Clin Endocrinol Metab. 1979 Jun;48(6):895-900. doi: 10.1210/jcem-48-6-895.
PubMed 447795
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury and Nonsteroidal Anti-inflammatory Drugs in Patients Undergoing High-risk Abdominal or Thoracic Surgery
- ClinicalTrials.gov ID
- NCT02553174
- Acronym / sponsor ID
- STUDY00003086
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: unable to recruit sufficient patients to satisfy study protocols
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 17 Sep 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.
The study will investigate the role of NSAIDs in the development of AKI in patients undergoing high-risk abdominal or thoracic surgery. The investigators hypothesize that the use of new urinary biomarkers will allow earlier detection of AKI than the current gold standard, i.e. changes in serum creatinine and/or urine output.
Detailed description
This study will be designed as a prospective observational trial. After obtaining Institutional Review Board (IRB) approval, patients will be recruited and consented from the Anesthesia Pre-Operative Clinic. On the day of surgery, baseline urine samples will be obtained at the initial insertion of the Foley catheter, after induction of anesthesia. Urine samples will also be collected from the Foley catheter in the immediate post-operative period shortly after the patient is admitted to the Intensive Care Unit (ICU). Urine samples will continue to be collected for 72 hours post-operatively, at 0600 (6am) and 1800 (6pm) each day from the indwelling Foley catheter, which is standard of care in the ICU. Urine samples will be labeled and stored as per the instructions provided in a commercially available kit; six urine samples total will be collected and stored per patient. The electronic medical record (EMR) will be reviewed to determine whether the patient received ketorolac, ibuprofen, or no NSAIDs intra-operatively and postoperatively (within 72 hours of the beginning of surgery). Daily serum creatinine measurements and hourly urine output, which are standards of care in the ICU, will be obtained from the EMR as well.
AKI will be diagnosed and staged according to KDIGO criteria, which are based on changes in creatinine and urine output. In all patients with "KDIGO-diagnosed AKI" and in a matched non-AKI group, we will also compare the time course of new urinary biomarkers, including but not limited to uNGAL, to that of serum creatinine and urine output. We will match patients according to their demographics as well as clinical characteristics, including co-morbidities, type of surgery and anesthesia technique. Comparing the time course of current clinical markers (serum creatinine and urine output) with that of new urinary biomarkers will allow us to assess their role in guiding future preventive interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | – | –Patients who receive ketorolac perioperatively |
| Caldolor | – | –Patients who receive Caldolor perioperatively |
| No NSAIDS | – | –Patients who do not receive NSAIDS perioperatively |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be identified by surgeon and by length of procedure. Patients presenting to the Anesthesia Preoperative Clinic who are scheduled to have surgery lasting longer than 4 hours by certain surgeons, and who are anticipated to recover postoperatively in the Surgical Intensive Care Unit will be given a recruitment/consent form explaining the study. The study will then be explained to potential patients by a member of the research team to determine recruitment eligibility and willingness to participate.
Key inclusion criteria (5 listed)
- age ≥ 21 (per manufacturer's instructions on the Nephrocheck kit)
- history of hypertension, whether medically treated or untreated
- scheduled for Anesthesia preoperative clinic visit
- scheduled to undergo prolonged intra-abdominal or intra-thoracic surgeries (defined as scheduled intraoperative time ≥ 4h). Intra-abdominal surgeries will include colorectal surgery, massive ventral hernia repairs, hepatobiliary surgery and gynecologic-oncology surgery. Intra-thoracic surgeries will include video-assisted thoracoscopic surgery (VATS)-assisted segmentectomy and lobectomies, as well as mediastinal mass excisions.
- will be anticipated to be admitted to the ICU for a minimum of 2-3 days post-operatively
Key exclusion criteria (3 listed)
- history of chronic kidney as defined by estimated glomerular filtration rate (GFR) <90
- patient taking NSAIDs on a daily basis
- patients with a reported allergy or intolerance to NSAIDs
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
Acute Kidney Injury
Time frame: 72 hours post-operatively
AKI defined by change in serum creatinine from baseline and change in urine output (KDIGO criteria)
1 secondary outcome
Urine biomarkers in AKI detection
Time frame: 72 hours post-operatively
Results and safety
The study was stopped early (reason given: unable to recruit sufficient patients to satisfy study protocols). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Background: PubMed 24764522Calvert S, Shaw A. Perioperative acute kidney injury. Perioper Med (Lond). 2012 Jul 4;1:6. doi: 10.1186/2047-0525-1-6. eCollection 2012.
- Background: PubMed 21975865Singbartl K, Kellum JA. AKI in the ICU: definition, epidemiology, risk stratification, and outcomes. Kidney Int. 2012 May;81(9):819-25. doi: 10.1038/ki.2011.339. Epub 2011 Oct 5.
- Background: PubMed 23394211Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.
- Background: PubMed 15312219Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.
- Background: PubMed 25005361Luo X, Jiang L, Du B, Wen Y, Wang M, Xi X; Beijing Acute Kidney Injury Trial (BAKIT) workgroup. A comparison of different diagnostic criteria of acute kidney injury in critically ill patients. Crit Care. 2014 Jul 8;18(4):R144. doi: 10.1186/cc13977.
- Background: PubMed 23388612Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.
- Background: PubMed 7910173Witzgall R, Brown D, Schwarz C, Bonventre JV. Localization of proliferating cell nuclear antigen, vimentin, c-Fos, and clusterin in the postischemic kidney. Evidence for a heterogenous genetic response among nephron segments, and a large pool of mitotically active and dedifferentiated cells. J Clin Invest. 1994 May;93(5):2175-88. doi: 10.1172/JCI117214.
- Background: PubMed 19428114Yang QH, Liu DW, Long Y, Liu HZ, Chai WZ, Wang XT. Acute renal failure during sepsis: potential role of cell cycle regulation. J Infect. 2009 Jun;58(6):459-64. doi: 10.1016/j.jinf.2009.04.003. Epub 2009 Apr 17.
- Background: PubMed 16707563Devarajan P. Update on mechanisms of ischemic acute kidney injury. J Am Soc Nephrol. 2006 Jun;17(6):1503-20. doi: 10.1681/ASN.2006010017. Epub 2006 May 17. No abstract available.
- Background: PubMed 17942417Rodier F, Campisi J, Bhaumik D. Two faces of p53: aging and tumor suppression. Nucleic Acids Res. 2007;35(22):7475-84. doi: 10.1093/nar/gkm744. Epub 2007 Oct 16.
- Background: PubMed 15276197Boonstra J, Post JA. Molecular events associated with reactive oxygen species and cell cycle progression in mammalian cells. Gene. 2004 Aug 4;337:1-13. doi: 10.1016/j.gene.2004.04.032.
- Background: PubMed 24675717Meersch M, Schmidt C, Van Aken H, Martens S, Rossaint J, Singbartl K, Gorlich D, Kellum JA, Zarbock A. Urinary TIMP-2 and IGFBP7 as early biomarkers of acute kidney injury and renal recovery following cardiac surgery. PLoS One. 2014 Mar 27;9(3):e93460. doi: 10.1371/journal.pone.0093460. eCollection 2014.
- Individual participant dataSharing planned: No
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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.
Anthony Bonavia, MD principal investigator
Milton S. Hershey Medical Center
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 Milton S. Hershey Medical Center 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Apr 2018. 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 was stopped early (reason given: unable to recruit sufficient patients to satisfy study protocols). Results are not available in the source record.
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?
Acute Kidney Injury (time frame: 72 hours post-operatively). 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 NCT02553174, which also lists 20 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 2 Apr 2018.