Dexmedetomidine and the Inflammatory Response in Pediatric Cardiac Surgery

NCT03163238 | Unknown Phase 2 DMC

• 1 other identifier: IRB000087632
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiopulmonary bypass-assisted surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. This may either be mild or lead to a more severe clinical condition. Inflammation after pediatric open heart surgery is a parameter affecting also duration of mechanical ventilatory support. Dexmedetomidine use was associated with a reduced increase in plasma IL-1, IL-6, TNF-a, and INF-g levels

Conditions

Cardiac Surgical Procedures

Keywords

Dexmedetomidine; Congenital Heart Disease; Cardiopulmonary Bypass; Interleukin

Outcome Measures

Primary Outcomes (1)

• Infilamatory response

  Interleukin 6 and 10

  Within the first 24 hours

Secondary Outcomes (4)

• Sedation score

  Within the first 24 hours

• Length of mechanical ventilaton

  Within 7 days

• Length of ICU stay

  Within 7 days

• Length of hospital stay.

  Within 7 days

Study Arms (2)

Group D

ACTIVE COMPARATOR

One syringe contain dexmedetomidine 0.5 mcg/kg diluted with normal saline in Dexmedetomidine group. Second syringe (50 ml) will contain normal saline (0.9%) in addition to Dexmedetomidine in addition to normal saline in Dexmedetomidine group. Concentration of Dexmedetomidine will be diluted according to the body weight so that we will fix the rate of infusion (1 ml/kg) to achieve a concentration of 0.5 mcg/kg/h in Dexmedetomidine group.

Drug: Dexmedetomidine

Group S

PLACEBO COMPARATOR

One syringe contain normal saline in 5 ml in Saline group. Second syringe (50 ml) will contain normal saline (0.9%) alone in rate of infusion (1 ml/kg) in Saline group

Drug: Normal saline

Interventions

Dexmedetomidine DRUG

Dexmedetomidine 0.5 mcg/kg diluted with normal saline in Dexmedetomidine group. Second syringe (50 ml) will contain normal saline (0.9%) in addition to Dexmedetomidine in addition to normal saline in Dexmedetomidine group. Concentration of Dexmedetomidine will be diluted according to the body weight so that we will fix the rate of infusion (1 ml/kg) to achieve a concentration of 0.5 mcg/kg/h in Dexmedetomidine group.

Also known as: Precedex

Group D

Normal saline DRUG

One syringe contain normal saline in 5 ml in Saline group. Second syringe (50 ml) will contain normal saline (0.9%) alone in rate of infusion (1 ml/kg) in Saline group

Also known as: Saline 0.9

Group S

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Inclusion Elective repair of congenital heart disease with cardiopulmonary bypass Exclusion Reintervention surgery requirement for blood products from the start of CPB, preoperative intake of corticosteroids, deep hypothermia, those with preoperative low cardiac output, those with non-palpable peripheral pulses before surgery (e.g., accompanying coarctation of the aorta) or ischemic time during cardiopulmonary bypass more than 90 minutes

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Dexmedetomidine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sayed K Abd-Elshafy, MD

  Associate profossor of anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sayed K Abd-Elshafy, MD

CONTACT

0882293592; sayed_k_72@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profossor of Anesthesiology

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 23, 2017
• Study Start: May 30, 2017
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

EG (1)