Buffered bicarbonate solutions for abdominal surgery

Phase 2

Completed

• Conditions: Major abdominal surgery; Metabolic and Endocrine - Other metabolic disorders; Surgery - Other surgery; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12619001228178
• Lead Sponsor: Professor Rinaldo Bellomo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-05
• Study Completion: 2022-11-30
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Adult aged 18 years or greater
Undergoing major abdominal surgery with an expected surgical duration of a minimum of 2 hours and an expected hospital admission of a minimum of 3 days
At risk of postoperative complications who have at least one of the following:
age equal to or greater than 70 years
known or document history of coronary artery disease
known or documented history of heart failure
diabetes with the receipt of oral hypoglycaemia agent and or insulin
preoperative serum creatinine greater than 200 micromol per litre
mobide obesity defined as a body mass index of equal to or greater than 35 kg per meter squared
peroperative serum albumin less than 30 gram/litre
anaerobic threshold of less than 12 ml per kilogram per minute
or
two or more of the following
ASA criteria 3 or 4
chronic respiratory disease
obesity of a body mass index between 30 and 35 kg per meter squared
aortic or peripheral vascular disease
preoperative haemoglobin less than 100 grams per litre
preoperative creatinine value of between 150-199 micromol/litre
anaerobic threshold 12-14 ml per kilogram per minute

Exclusion Criteria

Urgent or time-critical surgery
ASA physical status 5
Chronic renal failure requiring dialysis
Pulmonary or cardiac surgery
Liver resection
Minor or intermediate surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum measurement of metabolic acidosis, reflected by standard base excess.[Arterial blood gas measurement immediately after surgery]

Secondary Outcome Measures

Name	Time	Method
Serum measurement of arterial blood electrolytes (sodium, potassium, calcium and chloride)[Immediately after surgery];Plasma lactate level[Immediately after surgery];Plasma creatinine[Daily evaluation of routine serum creatinine measurements from the immediate end of surgery until the date of hospital discharge.];Markers of endothelial function,glycocalax, as measured by plasma sydecan and heparan sulfate levels[Immediately at the end of surgery];Markers of endothelial function,glycocalax, as measured by urine sydecan and heparan sulfate levels[immediately post surgery]