A study to develop and evaluate a hydration plan for kidney protection during coronary angioplasty

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Hydration strategy protocol: The experimental group will receive fluid after categorization, as per the Hydration Strategy Protocol. The fluid will be continued in pre‐procedural(2 hours prior to PCI), intra‐procedural(depending on case), and post‐procedural phases (6 hours). The monitoring of serum creatinine will be done at 0, 24, 48, 72 hours & 7th day respectively. Safety Endpoint : If the patient develops any life‐threatening conditions like cardiac arrest during the procedure, pulmonary edema, sustained ventricular arrhythmias or need for RRT. Duration of the study: 2 hours prior to PCI to 6 hours post‐PCI. Control Intervention1: Current practice: No preprocedural fluid Maintain NPO status 6 hours prior to procedure Receiving IV fluids during the procedure as per the clinical requirement If serum creatinine is within in normal range patient doesn t receive post‐procedural fluid For those patients with serum creatinine level 1.5 mg/dL, post‐procedural fluid is given based on EF . i.e.EF 40% (reduced): no fluid, EF 50% (preserved) & EF 40‐50% (mid‐range) will get at the rate of 70‐ 100mL /hour. Serum creatinine will be measured just like the intervention group. Control Intervention2: Current Practice: The current practice as followes, No preprocedural fluid given in this group. Maintain NPO status 6 hours prior to procedure. Receives IV fluids during the procedure as per the clinical requirement. If serum creatinine is within the normal range, the patient doesn t receive post‐procedural fluid. For those patients with serum creatinine level 1.5 mg/dL, post‐procedural fluid is given based on EF . i.e.EF 40% (reduced): no fluid, EF 50% (preserved) & EF 40‐50% (mid‐range) will get at the rate of 70‐ 100mL /hour. Serum creatinine will be measured just like the intervention group. CONDITION: PRIMARY OUTCOME: 1.To develop a Hydration Strategy Protocol for preventing CIN following PCI. ; 2.To evaluate the effect of the Hydration Strategy Protocol on the incidence of CIN following PCI.Timepoint: baseline, 24hour, 48 hour, 72hour and on the 7th day after PCI. SECONDARY OUTCOME: 1. To study the effect of the Hydration Strategy Protocol on selected outcomes in patients undergoing PCI. ; 2. To correlate the change in serum creatinine level with different clinical parameters of patients undergoing PCI.Timepoint: serum creatinine level will be measured at baseline, 24hour, 48 hour, 72hour & on the 7th day after PCI. ; Clinical parameters will be measured at baseline, 24hour, 48 hour. INCLUSION CRITERIA: Over 18 years old Scheduled for any PCI procedure in AIIMS Bhubaneswar. Signed informed consent.
Epistemonikos ID: 120db6d45023b8e08869751c95501d3e54da7c67
First added on: Oct 08, 2026