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Prospective, randomised, controlled, open clinical study of sodium bicarbonate Ringer injection vs saline hydration for the prevention of acute kidney injury after contrast media in patients with chronic kidney disease

Prospective, randomised, controlled, open clinical study of sodium bicarbonate Ringer injection vs saline hydration for the prevention of acute kidney injury after contrast media in patients with chronic kidney disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079751
Enrollment
Unknown
Registered
2024-01-11
Start date
2024-01-11
Completion date
Unknown
Last updated
2024-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute kidney injury after contrast media

Interventions

test subjects:hydrated by Sodium bicarbonate Ringer injection
control subjects:hydrated by saline (medicine)

Sponsors

Department of Emergency, Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1: Diagnosis of coronary atherosclerotic heart disease 2: Need for coronary angiography or percutaneous coronary intervention 3: Cardiac function class I-II (killips classification/New York Heart Association functional classification) 4: eGFR < 60mL/min/1.73m2(level-modifed Modifcation of Diet in Renal Disease formula ,MDRD) 5: Informed consent signed by the patient or immediate family members

Exclusion criteria

Exclusion criteria: 1: eGFR < 15mL/min/1.73m2(level-modifed Modifcation of Diet in Renal Disease formula ,MDRD) or requires dialysis treatment 2: Used intravascular contrast within 3 days 3: Acute pulmonary oedema 4: Hypotension (systolic blood pressure <90 mmHg) 5: Severe heart valve disease 6: Organ transplantation, history of malignant tumours 7: contrast medium allergy 8: Liver dysfunction, coagulation disorders 9: Presence of infection (or severe infection) 10: Acid-base imbalance, electrolyte disorders 11: Nephrotoxic drugs such as chemotherapeutic agents, non-steroidal antipyretic analgesics, amphotericin, aminoglycoside antimicrobials, etc., taken within 1 month 12: Metformin use within 48h prior to surgery(CAG or PCI) 13: Pregnant or breastfeeding women 14: Patients whose death is considered inevitable 15: hypothyroidism 16: hypermagnesemia 17: Other conditions considered by the investigator to be unsuitable for enrolment

Design outcomes

Primary

MeasureTime frame
creatinine;Cystatin C;plasma NGAL(neutrophil gelatinase-associated lipocalin);

Secondary

MeasureTime frame
plasma NT-proBNP;Contrast agent dosage;major adverse cardiac events(MACE);

Countries

China

Contacts

Public ContactDeya Shang

Shandong Provincial Hospital

sdslyysdy@126.com+86 135 8906 9627

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026