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Perioperative use of crystalloids in patients undergoing open radical cystectomy: balanced Ringer?s maleate vs G5-K solution

Perioperative use of crystalloids in patients undergoing open radical cystectomy: balanced Ringer?s maleate vs G5-K solution - a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN32976792
Enrollment
44
Registered
2013-11-21
Start date
2014-07-14
Completion date
Unknown
Last updated
2020-08-24

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

Conditions

Bladder disease resulting in cystectomy and urinary diversion Urological and Genital Diseases Acquired absence of other organs of urinary tract

Interventions

According to the randomization, an equal number of patients will be allocated to receive the Ringerfundin® solution or the G5-K crystalloid solution as baseline infusion during the whole time that an

Sponsors

Bern University Hospital (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or over 2. Cystectomy with urinary diversion 3. American Society of Anaesthesiologists (ASA) classification II and III 4. Informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant, breastfeeding women (exclusion for surgery per se) 2. Congestive heart failure [New York Heart Association (NYHA) classification =3] 3. Hepatic disease (prothrombin ratio <50%) 4. Significant renal dysfunction (estimated glomerular filtration rate <45 ml/min)

Design outcomes

Primary

MeasureTime frame
First defecation (return of bowel function) postoperatively

Secondary

MeasureTime frame
1. First flatus 2. Positive fluid balance (body weight difference postoperatively vs preoperatively) 3. Incidence of kidney function disorders according to the RIFLE classification 4. Difference in pH 24 h postoperatively (metabolic acidosis defined as hyperchloremia, normal anion gap, low plasma bicarbonate) 5. Changes in plasma and urine osmolality during the duration of infusion 6. Incidence of hypernatriemia during the duration of infusion 7. Incidence of hyperchloremia during the duration of infusion 8. Incidence of hypokaliemia during the duration of infusion 9. Changes in plasma renin, aldosterone, arginin vasopressin and brain natriuretic peptide (BNP) levels 10. Changes in neutrophil gelatinase-associated lipocalin (NGAL) urine values

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026