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Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury

Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury Following Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy: a Double-blind Randomized Clinical Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02641938
Enrollment
38
Registered
2015-12-30
Start date
2015-12-31
Completion date
2017-11-30
Last updated
2018-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Tumor

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.

Interventions

DRUGDexmedetomidine

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

DRUGNormal Saline

Control group :IV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Creatinine clearance from baselinePostoperative day 1,2,3,4,5,6,7Assessment of the creatinine clearance which reflects kidney function during postoperative 7 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026