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comparison the effect of hypertonic saline and sodium bicarbonate on early graft function in kidney transplantation

Effect of hypertonic saline 5% and sodium bicarbonate 8.4% on early graft function and the urinary levels of IL-18 and Neutrophil Gelatinase-associated Lipocalin (NGAL) as biomarkers of acute kidney injury in patients receiving kidney transplants from deceased donors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013122815841N1
Enrollment
60
Registered
2014-01-16
Start date
2013-09-23
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

kidney transplantation. Kidney transplant status

Interventions

Intervention 1: hypertonic saline group: 4ml/kg hypertonic saline 5% is administered before declamping during kidney transplant procedure. Intervention 2: control group
60 ml/kg normal saline solution administered during kidney transplant procedure to maintain CVP between 8 and 15 cm H2O. Intervention 3: sodium bicarbonate group: during kidney transplant procedure p
Treatment - Drugs
hypertonic saline group: 4ml/kg hypertonic saline 5% is administered before declamping during kidney transplant procedure.
control group
60 ml/kg normal saline solution administered during kidney transplant procedure to maintain CVP between 8 and 15 cm H2O
sodium bicarbonate group: during kidney transplant procedure pH is controlled tightly based on BD values by administration of sodium bicarbonate 8.4% and BE maintained above -5 m mol/L.

Sponsors

Research Council of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:patients candidate for a kidney transplant from deceased donor;the ages of 18 to 65;left ventricular ejection fraction >30%. Exclusion criteria:sever acidosis (pH5.5 or serum K150 or serum Na<135;blood product transfusion

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Serum creatinin. Timepoint: befor,0,6,12,24hr after operation and 2,3 and 7 days after transplant. Method of measurement: jaffe method.;BUN. Timepoint: befor,0,6,12,24hr after operation and 2,3 and 7 days after transplant. Method of measurement: colorimetric method.;Urin volume. Timepoint: recovery, 6, 12, 24, 48 hr after operation. Method of measurement: obsevation.;NGAL. Timepoint: 0,24,48 hr after operation. Method of measurement: ELISA.;IL-10. Timepoint: 0,24,48 hr after operation. Method of measurement: ELISA.—

Secondary

MeasureTime frame
Base deficit. Timepoint: before and every 30 minutes during operation. Method of measurement: ABG analyzer.;Serum K. Timepoint: before and during operation. Method of measurement: flame photometry.;HCO3. Timepoint: before and every 30 minutes during operation. Method of measurement: ABG analyzer.;PCO2. Timepoint: before and every 30 minutes during operation. Method of measurement: ABG analyzer.;Serum Cl. Timepoint: before and during operation. Method of measurement: flame photometry.;Serum Na. Timepoint: before and during operation. Method of measurement: flame photometry.;PO2. Timepoint: before and every 30 minutes during operation during operation. Method of measurement: mmHg-ABG analyzer.;PH. Timepoint: before and every 30 minutes during operation. Method of measurement: ABG analyzer.—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarhad Etezadi

Tehran University of Medical Sciences

etezadi@tums.ac.ir+98 910 212 1843

Outcome results

None listed

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