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

Not Applicable

Completed

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

• Registration Number: ISRCTN32976792
• Lead Sponsor: Bern University Hospital (Switzerland)

Brief Summary

2014 protocol in http://www.ncbi.nlm.nih.gov/pubmed/25005045 2016 results in https://pubmed.ncbi.nlm.nih.gov/27416541/ (added 14/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-21
• Study Completion: 2015-06-09
• Last Update Posted: 24 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First defecation (return of bowel function) postoperatively

Secondary Outcome Measures

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