NCT01117519CompletedPhase 4
Impact of a Balanced Infusion Solution Compound of 50% Crystalloid and 50% Colloid Versus an Unbalanced Infusion Solution of 100% Crystalloid Within a Goal-directed Hemodynamic Protocol on Acid-base Balance
Charite University, Berlin, Germany1 site in 1 country40 target enrollmentStarted: May 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Standard Base Excess
Study Overview
Brief Summary
The purpose of this study is to determine whether the administration of a compound of balanced infusion solutions including 50% crystalloid and 50% colloid has a positive impact on acid-base balance in elective hip replacement surgery. The application of the study medication will be carried out through a goal-directed intraoperative therapy by transoesophageal doppler.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients at the age of 60 and above who want to undergo an elective hip replacement surgery in the center of musculoskeletal surgery
- •Offered patient information and written informed consent
Exclusion Criteria
- •Participation in another trial according to the German Drug Law 30 days to and during the study
- •Lacking willingness to save and hand out data within the study
- •Accommodation in an institution due to an official or judicial order
- •(Unclear) history of alcohol or substances disabuse
- •Absent knowledge of german language
- •Analphabetism
- •Allergy to hydroxyethyl starch or other ingredients of the intravenous solutions
- •For women: Pregnancy or positive pregnancy test within the preoperative screening
- •Operation due to case of emergency, polytrauma or pathologic fracture
- •Only use of regional anaesthesia
- •American Society of Anaesthesiologists (ASA) classification greater than III
- •Peripheral or central edema
- •AIDS (according to the CDC-classification of HIV-infection: category C)
- •Rheumatoid disease under treatment with Anti-TNF-alpha-Ab and/or high-dose-corticoid-treatment
- •Immunosuppression therapy
- •History of bleeding tendency (e.g. von-Willebrand-disease, thrombocytopenia)
- •Derailed metabolic disorder (e.g. Diabetes mellitus (Glucose > 300 mg/dl) during the preoperative screening)
- •Known history of electrolyte disturbance (e.g. Hyperkalemia > 5.8 mmol/l, Hypernatraemia > 155 mmol/l)
- •Known history of acid-base-dysbalances
- •History of intracranial hemorrhage within one year of participation in the study
- •Neurological or psychiatric disease with limited contractual capability
- •Advanced disease of the oesophagus or upper respiratory tract
- •Operation in the area of the oesophagus or nasopharynx within the last two months
- •CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV
- •Liver disease (CHILD B or C cirrhosis, end-stage liver disease (MELD-score greater than 10))
- •Conditions after acute or chronic pancreatitis
- •Renal insufficiency (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis)
Arms & Interventions
unbalanced infusion solution
Active Comparator
Intervention: Infusion Therapy (Drug)
balanced infusion solution compound
Active Comparator
Intervention: Infusion Therapy (Drug)
Outcomes
Primary Outcomes
Standard Base Excess
Time Frame: up to 2 days
After administration of 2 litres of study medication. In recovery room. On general ward.
Secondary Outcomes
- Discharge Criteria, Length of Hospital Stay(5 days up to hospital discharge)
- SID (strong ion difference)(up to 2 days)
- Hemodynamic Stability(up to 6 days)
- Fluid Loss of Drainage(up to 6 days)
- Organ Function/Dysfunction(up to 6 days)
- Incidence of Infections(up to 5 days)
- Pain(up to 6 days)
- Mobilisation(up to 6 days)
- Incidence of Delirium(up to 6 days)
- Incidence of Postoperative Cognitive Deficit (POCD)(up to 90 days after surgery)
Investigators
Claudia Spies
Prof. MD, Director of the Dept. of Anaesthesiology and Intensive Care Medicine, CVK, CCM
Charite University, Berlin, Germany
Study Sites (1)
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