Cardiopulmonary BypassPhase 1NCT06917859
Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass
A Phase 1 study testing Methylprednisolone group in people with Cardiopulmonary Bypass and AKI - Acute Kidney Injury, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the planned study is to assess the prophylactic effect of intraoperative administration of a single dose of methylprednisolone 2 (mg/kg) in decreasing the incidence of postoperative acute kidney injury after cardiac surgeries with cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiopulmonary Bypass, AKI - Acute Kidney Injury
- What is being tested?
- Methylprednisolone group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Sex: Both sexes.
- Patients with American Society of Anesthesiologists (ASA) score III-IV.
- Patients scheduled for any kind of elective cardiac surgical procedure requiring cardiopulmonary bypass (e.g., coronary artery bypass grafting (CABG), valve repair/replacement, or combined procedures (
Who cannot join
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- Diabetic patients with HbA1C >6.5
- Moderate to severe hepatic diseases (Child B-C)
- Hepatic dysfunction: INR > 1.5, serum albumin < 2.9 g%.
- Renal dysfunction (serum Creatinine level >1.3 mg/dl, or GFR < 80 ml/min./1.73/m2
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- Patients with a recent history of AKI.
- Patients undergoing urgent cardiac surgery.
- Patients undergoing cardiac surgeries with deep hypothermic total circulatory arrest.
- Planned off-pump procedure.
- Any cardiac surgery exceeds 45 minutes on Aortic cross clamp.
- Patients requiring high doses of inotropes and/or vasopressors intraoperative or postoperative (high-dose dopamine is defined as peak doses of >15 μg/kg/min, high-dose norepinephrine is defined as peak dose >0.1 μg/kg/min, high-dose epinephrine is defined as peak dose >0.1 μg/kg/min)
- Delayed extubation for more than 6 hours postoperative.
- Patients developed postoperative complications as (septic shock and bleeding)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abdelrahman Atef Atef, M.B., B.Ch Faculty of Medicine contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Abbasia, 00202
Abdelrahman Atef Dr.Abdelrahman, M.B., B.Ch Faculty of Medicine, 01091541157, abdelrahman.atef@med.asu.edu.eg
About this study
Official title: Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass: A Randomized Double-Blinded Clinical Study
The aim of the planned study is to assess the prophylactic effect of intraoperative administration of a single dose of methylprednisolone 2 (mg/kg) in decreasing the incidence of postoperative acute kidney injury after cardiac surgeries with cardiopulmonary bypass.
Read the detailed description
Patients undergoing any type of elective cardiac surgical procedure requiring CPB will be randomly assigned into one of the following groups
- Placebo group / Control group will receives normal saline as a placebo after the induction of anesthesia and before initiating CPB.
- Methylprednisolone group / Interventional group receives a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB.
Measurements:
Primary outcome:
Incidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria.
Secondary outcome:
- Incidence of postoperatively hyperglycemia (blood glucose level of ≥ 140 mg/dl) for 7 days,
- Duration of ICU stay,
- Length of hospital stay (LOS),
- Incidence of wound infection,
- Incidence of peptic ulcer,
- Incidence of sepsis.
- Conditions
- Cardiopulmonary Bypass, AKI - Acute Kidney Injury
- Being tested
- Methylprednisolone group
- Keywords
- AKI, CPB
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone groupDrug
In this study patients will be given a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | (Placebo group / Control group) will receive normal saline as a placebo after the induction of anesthesia and before initiating CPB. |
| Methylprednisolone group | Active comparator | (Methylprednisolone group ) receive a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB. Receives: Drug: Methylprednisolone group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of occurrence of postoperative acute kidney injury
Incidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria.
Measured: 7 days post-operative
Secondary outcomes (6)
Incidence of postoperatively hyperglycemia
- Incidence of postoperatively hyperglycemia (blood glucose level of ≥ 140 mg/dl).
Measured: 7 days post-operative
Duration of ICU stay,
Duration of ICU stay,
Measured: 7 days post-operative
Length of hospital stay
Length of hospital stay
Measured: 14 Day post-operative
Incidence of wound infection
Incidence of wound infection
Measured: 7 days post-operative
Incidence of peptic ulcer
Monitoring attacks of hematemesis or melena
Measured: 7 days post-operative
Incidence of sepsis
Incidence of sepsis.
Measured: 7 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917859
- Sponsor's protocol ID
- MD47/2025
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass: A Randomized Double-Blinded Clinical Study
- ClinicalTrials.gov ID
- NCT06917859
- Acronym / sponsor ID
- MD47/2025
- Conditions
- Cardiopulmonary Bypass, AKI - Acute Kidney Injury
- Keywords
- AKI, CPB
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the planned study is to assess the prophylactic effect of intraoperative administration of a single dose of methylprednisolone 2 (mg/kg) in decreasing the incidence of postoperative acute kidney injury after cardiac surgeries with cardiopulmonary bypass.
Detailed description
Patients undergoing any type of elective cardiac surgical procedure requiring CPB will be randomly assigned into one of the following groups
- Placebo group / Control group will receives normal saline as a placebo after the induction of anesthesia and before initiating CPB.
- Methylprednisolone group / Interventional group receives a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB.
Measurements:
Primary outcome:
Incidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria.
Secondary outcome:
- Incidence of postoperatively hyperglycemia (blood glucose level of ≥ 140 mg/dl) for 7 days,
- Duration of ICU stay,
- Length of hospital stay (LOS),
- Incidence of wound infection,
- Incidence of peptic ulcer,
- Incidence of sepsis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –(Placebo group / Control group) will receive normal saline as a placebo after the induction of anesthesia and before initiating CPB. |
| Methylprednisolone group | Active comparator | Drug: Methylprednisolone group(Methylprednisolone group ) receive a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years.
- Sex: Both sexes.
- Patients with American Society of Anesthesiologists (ASA) score III-IV.
- Patients scheduled for any kind of elective cardiac surgical procedure requiring cardiopulmonary bypass (e.g., coronary artery bypass grafting (CABG), valve repair/replacement, or combined procedures (
Key exclusion criteria (14 listed)
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- Diabetic patients with HbA1C >6.5
- Moderate to severe hepatic diseases (Child B-C)
- Hepatic dysfunction: INR > 1.5, serum albumin < 2.9 g%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone groupIn this study patients will be given a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB. | Drug | Methylprednisolone group |
Primary outcome
Incidence of occurrence of postoperative acute kidney injury
Time frame: 7 days post-operative
Incidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria.
6 secondary outcomes
Incidence of postoperatively hyperglycemia
Time frame: 7 days post-operative
Duration of ICU stay,
Time frame: 7 days post-operative
Length of hospital stay
Time frame: 14 Day post-operative
Incidence of wound infection
Time frame: 7 days post-operative
Incidence of peptic ulcer
Time frame: 7 days post-operative
Incidence of sepsis
Time frame: 7 days post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abdelrahman Atef Atef, M.B., B.Ch Faculty of Medicine contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methylprednisolone group in people with Cardiopulmonary Bypass and AKI - Acute Kidney Injury, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Atef Atef, M.B., B.Ch Faculty of Medicine (+201091541157, abdelrahman.atef@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of occurrence of postoperative acute kidney injury (time frame: 7 days post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.