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NCT Number: NCT02641938

Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury

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

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Key information

Conditions

Malignant Tumor Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GangnamSH

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

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

Drug

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

Primary outcomes

  1. Change of Creatinine clearance from baseline

    Time frame: Postoperative day 1,2,3,4,5,6,7

    Assessment of the creatinine clearance which reflects kidney function during postoperative 7 days

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 30, 2015
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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