Effect of Dexmedetomidine on Acute Kidney Injury After Ascending Aortic Surgeries

June 7, 2026 updated by: Ain Shams University

Effect of Dexmedetomidine on Acute Kidney Injury After Ascending Aortic Surgeries: Placebo-controlled, Randomised Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Type of Study: A prospective, randomized, comparative, single-center, double-blinded, interventional clinical trial study.

Study Setting: Cardiac Intensive care, Cardiac Surgical Academy Faculty of Medicine - Ain Shams University, Cairo, Egypt.

Study Period: 1 year after approval of the ethical committee of the faculty of medicine, Ain Shams University.

Study Population: 78 patients will be endorsed as follows:

  1. 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
  2. Group (B): the control group will receive an infusion of an equivalent volume of a 0.9% saline for the same duration

Inclusion Criteria:

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

Exclusion Criteria:

  • 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. Sampling Method: Simple random sampling Sample Size: Sample size was calculated using G*Power software version 3.1.9.2 program, setting the type-1 error (α) at 0.05 and the power (1-β) at 0.9. Result from previous study showed that the incidence of AKI was 13% among cases in dexmedetomidine group, compared to 54% among control group as reported by . Calculation according to these values produced a sample size of 38 cases per group (78 total) with an estimated drop-out rate of 20%.

Ethical Considerations: The procedure will be done under the supervision of the main supervisor. The study will be performed after approval from the Research Ethical Committee (REC), Faculty of Medicine, Ain Shams University. Informed and written consent will be obtained from all participants before starting the study. The study protocol will be explained to the participants before taking their consent to participate in the study.

Study Tools:

All the used interventional medications are approved by the Food and Drug Administration (FDA) and the Pharmacy and Therapeutics Committee (PTC) of Ain Shams University Hospitals.

Dexmedetomidine Hydrochloride: PrecedexR 200 µg/2ml vial , Pfizer, Egypt.

Study Procedures and Intervention:

Consented and enrolled 78 patients will be randomly assigned to one of the following 2 groups:

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

A.Preoperative settings:

All patients will be fasting for 8 hours. All patients will have their medical and anesthetic history taken with a full physical examination. Revision of radiological images (ECHO, Carotid Duplex, LL Arterial duplex and Coronary angiography) and routine investigations including CBC, coagulation profile, electrolytes, kidney, and liver profiles will be done.

B.Intraoperative settings:

All subjects will receive institutionally standardised anaesthetic care and CPB management according to our institutional protocol.

Standard monitoring with electrocardiogram (ECG) for heart rate (beats/min), pulse oximetry for (SpO2 as a percentage),trans-oesophageal echocardiography, and invasive monitoring, including radial, femoral artery catheterisation will be conducted in all cases

Immediately after induction of anesthesia :

Patients of group A will receive Dexmedetomidine which will be mixed with 0.9% saline to achieve a concentration of 4ug/ml which will continuously infused at a rate of 0.4 ug/kg/hr for 24 hours.

Patients of group B will receive an infusion of an equivalent volume of a 0.9% saline for the same duration

If hypotension occurred MAP will be maintained at 60-80 mm Hg using norepinephrine (maximum of 0.5ug/kg/min/) as necessary .

If bradycardia occurred low dose of atropine (0.01 mg\kg) can be given as necessary.

Institutionally standardised perioperative fluid and transfusion management will be conducted. Acute surgical bleeding or chest tube drainage will be compensated with allogeneic packed erythrocytes, depending on the haematocrit. Packed erythrocytes will be transfused when the haematocrit will be <20% during CPB or <25% otherwise. Fresh frozen plasma (FFP) and platelets will be transfused at the discretion of the attending anaesthesiologist and cardiac surgeon during surgery (Cho et al., 2016).

C.Postoperative settings:

After operation, if bleeding exceeded 200 m/h for 2 consecutive h, FFP, platelets, or both will be transfused if the international normalised ratio is greater than 1.3 or the platelet count is less than 50x103/ml. If oliguria occurred (urine output <1 ml/kg/h for 30 min), the volume status and appropriateness of haemodynamic values will be judged to determine the direction of treatment in all patients. Unless patients will be judged to have excessive circulating volume, three fluid boluses (200 ml of balanced crystalloid) will be administered. If the response will not be adequate 15 min after the third bolus or the patients' volume and haemodynamic status deemed appropriate, 5 mg furosemide will be administered intravenously, with repeated administrations every 30 min with escalating doses until the desired effect will be produced. Renal replacement therapy will be initiated if refractory oliguria, fluid overload, hyperkalaemia (>6.5 mEq\L) or rapidly increasing potassium levels, signs of uraemia, or metabolic acidosis (pH <7.1) occurred. Blood glucose levels will be adjusted according to the institutionally standardised insulin protocol .

Measurements and Data collection:

Demographic data as:

Age (years), sex (m/f), body, comorbidities, prior cardiac/aortic surgery

Introperative variables:

,Type of aortic surgey,duration of anaesthesia, CPB, Aortic cross clamp (ACC), and hypothermic circulatory arrest, fluid balance, , chest tube drainage, urine output, blood products transfusion, and the use of vasoconstrictors and inotropes for 48 h after surgery will be recorded after surgery. Haemodynamic data and laboratory data including serum creatinine, serum urea,serum electrolytes,haematocrit, white blood cell count, and C-reactive protein level will be serially assessed immediately after surgery and 12, 24 h, after surgery.

Outcomes:

The primary outcome: The primary outcome will be 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 be assessed before surgery, upon ICU arrival, at least once a day until postoperative day 5.

Secondary outcomes: For secondary outcomes, will be delirium, length of ICU stay, and inhospital mortality

Major morbidity end points:permenant stroke,hemostatic re-exploration,prolonged ventilator care> 48 hours

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Egypt
      • Cairo, Egypt, Egypt, 00202
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ●Age: 20-70 yrs

    • Scheduled for aortic surgery under CPB

Exclusion Criteria:

  • ●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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: active arm
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
the effect of dexmedetomidine administration on AKI after ascending aortic surgeries requiring CPB in a placebo-controlled randomised controlled trial.
Placebo Comparator: control arm
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)
Group (B): the control group will receive an infusion of an equivalent volume of a 0.9% saline for the same duration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
measurement of kidney function
Time Frame: Serum creatinine levels will beassessed before surgery, at least once a day until postoperative day 5
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
delirium
Time Frame: perioperative
Delirium is a serious change in mental abilities. It results in confused thinking and a lack of awareness of someone's surroundings
perioperative
inhospital mortality
Time Frame: perioperative
the state of being subject to death
perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: galal EL-KADY, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMASU MD43/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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