Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury
1 other identifier
interventional
38
1 country
1
Brief Summary
To investigate the renal protective effect of dexmedetomidine in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 20, 2015
CompletedFirst Posted
Study publicly available on registry
December 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedJanuary 2, 2018
December 1, 2017
1.9 years
December 20, 2015
December 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change of Creatinine clearance from baseline
Assessment of the creatinine clearance which reflects kidney function during postoperative 7 days
Postoperative day 1,2,3,4,5,6,7
Study Arms (2)
Dexmedetomidine
EXPERIMENTAL1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion after induction of anesthesia until the completion of the surgery
Normal Saline
PLACEBO COMPARATORIV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery
Interventions
Dexmedetomidine group :1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion after induction of anesthesia until the completion of the surgery
Control group :IV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery
Eligibility Criteria
You may qualify if:
- Diagnosis of malignant tumor with peritoneal metastasis
- Scheduled for elective cytoreduction and hyperthermic intraperitoneal chemotherapy
You may not qualify if:
- Preoperative chronic kidney disease stage ≥4 defined by KDOQI ( eGFR \< 30 mL/min/1.73m2)
- Congestive heart failure
- Atrioventricular block \> 1st degree
- Bradycardia \< 45 beat per minute
- History of myocardial infarction within 3 months
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GangnamSH
Seoul, South Korea
Related Publications (1)
Song Y, Kim DH, Kwon TD, Han DW, Baik SH, Jung HH, Kim JY. Effect of intraoperative dexmedetomidine on renal function after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: a randomized, placebo-controlled trial. Int J Hyperthermia. 2019;36(1):1-8. doi: 10.1080/02656736.2018.1526416. Epub 2018 Oct 25.
PMID: 30354794DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji-Young Kim, MD
Yonsei University Medical College Gangnam Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Yonsei University Medical College
Study Record Dates
First Submitted
December 20, 2015
First Posted
December 30, 2015
Study Start
December 1, 2015
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
January 2, 2018
Record last verified: 2017-12