Effect of Dexmedetomidine on Acute Kidney Injury After Ascending Aortic Surgeries

NCT06958367 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: FMASU MD43/2025
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Acute kidney injury (AKI) is a frequent and serious complication after ascending aortic surgeries requiring cardiopulmonary bypass (CPB). Dexmedetomidine, a selective α-2 adrenoreceptor agonist, may reduce AKI because of its sympatholytic and anti-inflammatory effects against ischaemia reperfusion injury. We investigate the effect of dexmedetomidine administration on AKI after ascending aortic surgeries requiring CPB in a placebo-controlled randomised controlled trial.

Conditions

Aki After Ascending Aortic Surgeries

Outcome Measures

Primary Outcomes (1)

• measurement of kidney function

  AKI will be diagnosed based on the AKIN criteria: Stage 1 was defined as a serum creatinine increase ≥1.5-2-fold above baseline or ≥0.3 mg/dl or urine output \<0.5 ml/kg/h for \>6 h; stage 2 was defined as a creatinine increase \>2-3-fold above baseline or urine output \<0.5 ml/kg/h for \>12 h; stage 3 was defined as a creatinine increase \>3-fold above baseline or \>4.0 mg/dl with an acute increase of 0.5 mg/dl, urine output \<0.3 ml/kg/h for 24 h, or anuria for 12 h

  Serum creatinine levels will beassessed before surgery, at least once a day until postoperative day 5

Secondary Outcomes (2)

• delirium

  perioperative

• inhospital mortality

  perioperative

Study Arms (2)

active arm

ACTIVE COMPARATOR

Group (A): will receive Dexmedetomidine which will be mixed with 0.9% saline to achieve a concentration of 4ug/ml which will be continuously infused at a rate of 0.4 ug/kg/hr for 24 hours starting immediately after anesthetic induction

Drug: Dexmedetomidine

control arm

PLACEBO COMPARATOR

Group (B): the control group will receive an infusion of an equivalent volume of a 0.9% saline for the same duration

Drug: Normal Saline (Placebo)

Interventions

Dexmedetomidine DRUG

the effect of dexmedetomidine administration on AKI after ascending aortic surgeries requiring CPB in a placebo-controlled randomised controlled trial.

active arm

Normal Saline (Placebo) DRUG

Group (B): the control group will receive an infusion of an equivalent volume of a 0.9% saline for the same duration

control arm

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ●Age: 20-70 yrs
• Scheduled for aortic surgery under CPB

You may not qualify if:

• ●Patient refusal to participate
• Congestive heart failure with a left ventricular ejection fraction \<45%
• Uncontrolled arrhythmia combined with unstable hemodynamics
• Acute coronary syndrome.
• Preoperative elevated kidney function (serum urea and serum creatinine). Use of ventricular assist devices

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AIN shams university

Cairo, Egypt, 00202, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• galal EL-KADY, MD

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

marco yassa, M.B.B.CH

CONTACT

+201002339054; marKo.ashraf@med.asu.edu.eg

walid nofal, MD

CONTACT

+201097121743; w201077@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: May 6, 2025
• Study Start: May 1, 2025
• Primary Completion: May 2, 2026
• Study Completion: May 3, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

EG (1)