The Effect of Dexmedetomidine on Kidney Perfusion in Paediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03425734
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Information provided by (Responsible Party):
Mai Madkour, Cairo University

Brief Summary:

I. Study design: open/ blinded randomized, controlled study.

II. Study setting and location:

The study will be conducted in Abul Reesh Paediatric Hospital Faculty of Medicine /Cairo University from 2016-2018.

III. Study population:

This controlled open/blinded labelled randomized study is designed to include 40 children of both sexes scheduled for open-heart surgery for total correction of congenital heart diseases.

IV. Eligibility Criteria:

Inclusion criteria;

  1. Paediatric patients of age group ranging from 6 months to 12 years .
  2. Patients with complex congenital heart disease undergoing open heart surgery for total correction of the cardiac anomaly using cardiopulmonary bypass.

Exclusion criteria;

  • Age less than 6 months or more than12 years.
  • Significant ventricular dysfunction (Ejection fraction < 40%).
  • Patients with pre-existing CNS disorders e.g.: seizures.
  • Patients with abnormal liver functions.
  • Pre-operative creatinine level >1.2 mg /dl.
  • Patients with history of diabetes mellitus.
  • Patients receiving NSAID for any reason. Study Protocol; The patients will be pre-medicated by atropine 0.01mg/kg, ketamine 0.03mg/kg and midazolam 0.02mg/kg IM, 30 minutes before induction of anesthesia. Standard ASA monitors, including electrocardiogram (ECG), pulse oximetry (Spo2), and non-invasive blood pressure cuff, and INVOS somatic oximeter probes will be placed on the renal area (on the back to the right or to the left from T10 to l2) will be placed on the patients before induction of anesthesia.

Anesthetic technique will be standardized for all the patients in the form of inhalational induction using sevoflurane 6% in a mixture of oxygen and air (1:1) to be followed by placement of peripheral intravenous cannula. Intubation will be facilitated by pancuronium 0.01 mg/kg IV and ventilation will be controlled using pressure mode aiming to maintain PCO2 between (30-35 mmHg). Anesthesia will be maintained by mixture of 2% sevoflurane in 1:1 oxygen: air till time of CPB.

A standard CPB technique will be used in all patients. Before aortic cannulation, patients will receive IV heparin 400 aiming to produce ACT value > 400 sec. A membrane oxygenator (minimax plus ;Medtronics Inc.,Anaheim,CA) will be used during CPB. Priming solution in the form of isotonic saline solution supplemented with heparin added to fresh whole blood in appropriate amounts to achieve a hematocrit 20-25% during CPB will be used. Furosemide in a dose of 1mg .kg-1.min-1 will be given to all patients. Venting of left heart will be performed with a left atrial vent inserted through a small incision at the inter-atrial septum . Anesthesia during CPB will be given by Sevoflurane administrated via a vaporizer inserted into the oxygenator gas supply with a constant gas flow 3 liter.min-1. A non-pulsatile roller pump (model10.10.00;Stocket instruments ;Munich, Germany) will be used and the pump flow will be adjusted at 2.4 to 2.6 L/min /m2 during the normothermic period targeting mean arterial blood pressure between 40 and 60 mmHg. If the MAP will fall below 40 mmHg despite full perfusion pressure, a bolus dose of 0.01-0.1 ng /Kg phenylephrine will be given. If MAP increased above 60 mmHg, a continuous infusion of nitroglycerin at a dose of 1-2 µ be given.

After application of aortic cross clamp and administration of cold cardioplegia solution (Saint Thomas cardioplegic solution, 20ml/Kg to be followed by doses of 10ml/Kg every 20 min.), time will be allowed to develop a stable level of perfusion pressure and moderate hypothermia (28°C-32°C).

These variables will be kept constant for at least 10 minutes after initiation of full flow CPB and initiation of the study sequence. Thereafter, patients will be randomely allocated to DEX group (Group D n=20) receiving dexmedetomidine in a dose of 3 mcg/kg over 10 minutes to be followed by an infusion of 1 mcg/kg/hr to be continued until the first 6 postoperative hours.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Drug: Dexmedetomidine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: The Effect of Dexmedetomidine on Kidney Perfusion in Paediatric Patients Undergoing Open Heart Surgery Guided by Near Infrared Spectroscopy: Randomized Controlled Study
Actual Study Start Date : May 20, 2017
Estimated Primary Completion Date : May 20, 2018
Estimated Study Completion Date : July 20, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: D group
The drug will be prepared in 50 ml saline 0.5 ml DEX (100mc/ml +49.5 cc saline 1ml=1mg), and the dose will be calculated according to body weight.
Drug: Dexmedetomidine
The drug will be prepared in 50 ml saline 0.5 ml DEX (100mc/ml +49.5 cc saline 1ml=1mg), and the dose will be calculated according to body weight.
Experimental: S group
50 ml saline
Drug: Dexmedetomidine
The drug will be prepared in 50 ml saline 0.5 ml DEX (100mc/ml +49.5 cc saline 1ml=1mg), and the dose will be calculated according to body weight.

Primary Outcome Measures :
  1. renal regional oxygen saturation [ Time Frame: 24 hours ]
    compares regional renal oxygen saturation measured by invos with and without dexmedetomidine infusion

Secondary Outcome Measures :
  1. urine output [ Time Frame: 24 hours ]
    measured across the day by urinary catheter

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • children 6m to 12 years complex congenital heart disease

Exclusion Criteria:

  • signifiacnt ventricular dysfunction pre-existing CNS disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03425734

Contact: Mai A Madkour 01223657694
Contact: Hany R Elgamal

Pediatric University Hospitals Recruiting
Cairo, Outside US And Canada, Egypt, 12555
Contact: Mai A Madkour    1223657694   
Sponsors and Collaborators
Mai Madkour
Study Chair: A Shash Anesthesia Dep

Responsible Party: Mai Madkour, lecturer, Cairo University Identifier: NCT03425734     History of Changes
Other Study ID Numbers: N19234
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action