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Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass

ConditionsCardiopulmonary BypassAKI - Acute Kidney Injury
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 (

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methylprednisolone group

    Drug

    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.

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Methylprednisolone groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of occurrence of postoperative acute kidney injury

Incidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria.

Time frame
7 days post-operative

Secondary outcomes

1

Incidence of postoperatively hyperglycemia

1\. Incidence of postoperatively hyperglycemia (blood glucose level of ≥ 140 mg/dl).

Time frame
7 days post-operative
2

Duration of ICU stay,

Duration of ICU stay,

Time frame
7 days post-operative
3

Length of hospital stay

Length of hospital stay

Time frame
14 Day post-operative
4

Incidence of wound infection

Incidence of wound infection

Time frame
7 days post-operative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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