Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-11-30

Brief Summary

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To investigate the renal protective effect of dexmedetomidine in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy

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Detailed Description

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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.

Conditions

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Malignant Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Dexmedetomidine

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Normal Saline

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Normal Saline

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No