Effect of Na/K citrate on contrast media-induced acute kidney injury

A clinical trial of the comparison of the effect of drug Na/K citrate per os plus hydration with hydration alone on serum creatinine in high-risk patients after receiving contrast

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015011618389N3

Enrollment

400

Registered

2015-04-30

Start date

2015-01-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Acute renal failure. Acute renal impairment

Interventions

Intervention 1: Intervention group: all of the patients will receive Na/K citrate (one hour before and four hours after contrast intake) in addition to intravenous hydration (2 litter normal saline fr

Treatment - Drugs

Intervention group: all of the patients will receive Na/K citrate (one hour before and four hours after contrast intake) in addition to intravenous hydration (2 litter normal saline from 2 h before to

Control group: All patients will receive intravenous hydration (2 litter of normal saline From 2 h before until 6 h after the contrast intake)

Eligibility

Sex/Gender

All

Age

20 Years to 90 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria are the existence of at least one risk factor of contrast-induced nephropathy, namely: 1- Moderate systolic heart failure [ (EF) Ejection Fraction between 30-45%]2- Diabetes mellitus 3- Older than 75 year-old 4- Moderate renal insufficiency (serum creatinine level between 1/5-2 mg/dl) 5- Hypotension (systolic blood pressure less than 90 mm Hg 6- Anaemia 7- History of hypertension. Exclusion criteria; 1- pregnancy and lactation 2- History of allergic reaction to contrast media 3- Occurrence of cardiogenic shock and pulmonary edema during study 4-Urgent catheterization 5- Serum creatinine level higher than 2 mg/dl and previous history of dialysis 6- Receiving contrast medium 48 h before and after the intervention 7- Receiving diuretics, N-acetylcystein, sodium bicarbonate, theophylline, dopamine, mannitol, fenoldopam, metformin and NSAID’S during the study 8- Requiring to continue hydration therapy (e.g., sepsis condition) 9-Severe heart failure [left ventricular ejection fraction (LVEF) less than 30%]

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum creatinine. Timepoint: Before and 48 h after contrast intake. Method of measurement: laboratory Kit (enzymatic method).;Urine PH. Timepoint: Before and 1 hour after citrate intake. Method of measurement: Urine dipstick.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeili Iranirad

Qom University of Medical Sciences and Health Services

lirani@muq.ac.irliranirad@gmail.com+98 25 3612 2717

Outcome results

None listed

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