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Postoperative Acute Kidney Injury in Patients Undergoing Prolonged Neurosurgical Operations

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ClinicalTrials.gov Identifier: NCT03486184
Recruitment Status : Not yet recruiting
First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ali Maher Abdel Salam Ahmed, Assiut University

Tracking Information
First Submitted Date March 22, 2018
First Posted Date April 3, 2018
Last Update Posted Date April 3, 2018
Estimated Study Start Date May 1, 2018
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2018)
the occurrence of AKI [ Time Frame: 2 days ]
BY using AKIN criteria.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Postoperative Acute Kidney Injury in Patients Undergoing Prolonged Neurosurgical Operations
Official Title Postoperative Acute Kidney Injury in Patients Undergoing Prolonged Neurosurgical Operations
Brief Summary Postoperative Acute Kidney Injury in Patients Undergoing Prolonged Neurosurgical Operations
Detailed Description
  • Postoperative acute kidney injury (AKI) is a highly prevalent and prognostically important complication in various surgical settings. Patients who developed postoperative AKI is independently associated with markedly increased morbidity, mortality1-8 and higher economic burden1.
  • AKI was defined by an increase in serum creatinine (SCr) ≥ 0.3 mg/dl or by an increase in SCr ≥ 50% and/or by a decrease in urine output to 0.5 ml/kg/hour for 6 hours, in the first 48 hours after surgery.
  • Patients who developed AKI had a higher total ICU costs, prolonged length of hospital and ICU stay, and longer duration of postoperative mechanical ventilation.
  • AKI has been studied in different surgical procedures especially cardiac & abdominal surgeries.
  • Kovacheva et al 2016 retrospective study included 1656 craniotomy patients from 1998 to 2011. The AKI used criteria was RIFLE (Risk, Injury, Failure, Loss of kidney function and End-Stage Renal Failure), they reported an incidence of 9.9% of postoperative AKI9.
  • Deng et al 2017 also reported an incidence of AKI up to 13.5% in patients undergoing neurosurgical surgery within the first 7 days. It was associated with independent risk factors included intraoperative blood loss, postoperative reoperation, use of mannitol during operation, concentration of Cystatin-C; a biomarker protein detecting early kidney injury before creatinine changes and postoperative APACHE II score10.
  • As the number of neurosurgical procedures has been increased worldwide and in our department as well with new types of prolonged neurosurgery e.g. Skull - Base - Major cerebrovascular beside major cranial tumor excision. It becomes a necessary to re-evaluate the incidence, factors behind AKI and outcome in such prolonged surgery.
  • In 2002, The Acute Dialysis Quality Initiative (ADQI) was created with primary goal was to create a uniform, accepted definition of AKI; hence RIFLE criteria was born. RIFLE is an acronym of Risk, Injury, Failure, Loss of Kidney Function & End-Stage Kidney Failure.
  • In 2004, The Acute Kidney Injury Network (AKIN) was formed. A report of the AKIN proposed the following criteria for AKI.
  • The AKIN criteria differ from the RIFLE criteria in several ways. The RIFLE criteria are defined as changes within 7 days, while the AKIN criteria suggest using 48 hours. The AKIN classification includes less severe injury in the criteria and AKIN also avoids using the glomerular filtration rate as a marker in AKI, as there is no dependable way to measure glomerular filtration rate and estimated glomerular filtration rate are unreliable in AKI.
  • Haase et al. 2009 in their comparative study between RIFLE and AKIN in cardiac surgery; found no difference between the AKI scores11.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Days
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients aged 18 years or older
Condition Postoperative Acute Kidney Injury
Intervention Diagnostic Test: Cystatin-C
  • Laboratory values will be obtained, including level of preoperative serum creatinine, complete blood count, coagulation profile and Cystatin-C (5 ml. venous sample).
  • Serum creatinine and hemoglobin will be measured after operation, and thereafter at least once a day as a part of routine clinical care. Postoperative serum Cystatin-C will measured only once.
Study Groups/Cohorts Not Provided
Publications * Deng Y, Yuan J, Chi R, Ye H, Zhou D, Wang S, Mai C, Nie Z, Wang L, Zhai Y, Gao L, Zhang D, Hu L, Deng Y, Chen C. The Incidence, Risk Factors and Outcomes of Postoperative Acute Kidney Injury in Neurosurgical Critically Ill Patients. Sci Rep. 2017 Jun 26;7(1):4245. doi: 10.1038/s41598-017-04627-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: March 27, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients aged 18 years or older who will do prolonged neurosurgical procedure, duration of surgery more than 4 hours and ASA 1-2-3.

Exclusion Criteria:

  • refusal of consent, preexisting renal transplantation, preexisting nephrectomy, presence of AKI before neurosurgical procedure, operation less than 4 hours, patients aged under 18 years, pregnancy and ASA 4-5.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ali M Abdel-Salam, Master +2 01008560550 alimelassal91@hotmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03486184
Other Study ID Numbers acute kidney injury
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ali Maher Abdel Salam Ahmed, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date March 2018