Back to resultsEffect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury
Primary Purpose
Malignant Tumor
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Normal Saline
Sponsored by
About this trial
This is an interventional prevention trial for Malignant Tumor
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of malignant tumor with peritoneal metastasis
- Scheduled for elective cytoreduction and hyperthermic intraperitoneal chemotherapy
Exclusion Criteria:
- 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
Sites / Locations
- GangnamSH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine
Normal Saline
Arm Description
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
IV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery
Outcomes
Primary Outcome Measures
Change of Creatinine clearance from baseline
Assessment of the creatinine clearance which reflects kidney function during postoperative 7 days
Secondary Outcome Measures
Full Information
NCT ID
NCT02641938
First Posted
December 20, 2015
Last Updated
December 29, 2017
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02641938
Brief Title
Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury
Official Title
Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury Following Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy: a Double-blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the renal protective effect of dexmedetomidine in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy
Detailed Description
A cytoreductive surgery and hyperthermic intraperitoneal chemotherapy may lead to the renal hypoperfusion, systemic inflammatory response, and oxidative stress. Dexmedetomidine has been known to protect the kidney against inflammation and oxidative stress in diverse clinical settings. It may also enhance a renal perfusion by inhibition of renal sympathoexcitation. We hypothesized administration of dexmedetomidine might protect the kidney in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Tumor
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
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
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
IV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Control group :IV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery
Primary Outcome Measure Information:
Title
Change of Creatinine clearance from baseline
Description
Assessment of the creatinine clearance which reflects kidney function during postoperative 7 days
Time Frame
Postoperative day 1,2,3,4,5,6,7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of malignant tumor with peritoneal metastasis
Scheduled for elective cytoreduction and hyperthermic intraperitoneal chemotherapy
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Young Kim, MD
Organizational Affiliation
Yonsei University Medical College Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
GangnamSH
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
30354794
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury
We'll reach out to this number within 24 hrs