Impact of Fluid Management Within a Goal-directed Hemodynamic Protocol on Acid-base Balance in Elective Trauma Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hemodynamic Instability

Intervention / Treatment
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* Drug: Infusion Therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: unbalanced infusion solution<br> | Drug: Infusion Therapy<br>* Based on changes of stroke volume measured by transoesophageal doppler patients during elective hip surgery will achieve either a unbalanced infusion solution, maximum dose of 100 ml/kg BW, or a compound of balanced infusion solution including 50% crystalloid and 50% colloid, each: maximum dose of 50 ml/kg BW. The study medication will be administered only during surgery.<br>|
| Active Comparator: balanced infusion solution compound<br> | Drug: Infusion Therapy<br>* Based on changes of stroke volume measured by transoesophageal doppler patients during elective hip surgery will achieve either a unbalanced infusion solution, maximum dose of 100 ml/kg BW, or a compound of balanced infusion solution including 50% crystalloid and 50% colloid, each: maximum dose of 50 ml/kg BW. The study medication will be administered only during surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Base Excess | After administration of 2 litres of study medication. In recovery room. On general ward. | up to 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SID (strong ion difference) | Change of the SID (strong ion difference) according to the stewart-approach of evalutation acid-base-dysbalances | up to 2 days | 
| Hemodynamic Stability | Doses and duration of therapy with catecholamins, number and duration of hypotensive episodes | up to 6 days | 
| Fluid Loss of Drainage | The quantity of fluids per day losing by drainage during the first three days after surgery | up to 6 days | 
| Discharge Criteria, Length of Hospital Stay | Time until fullfilling the hospital discharge criteria (measured by the postanesthesia discharge scoring system (PADSS)), and length of hospital stay | 5 days up to hospital discharge | 
| Organ Function/Dysfunction | (Cumulative) frequency of postoperative organ dysfunctions (cerebral, cardiac, pulmonary, renal, gastrointestinal) | up to 6 days | 
| Incidence of Infections | Perioperative Incidence of infections (according to the Centers of Disease and Prevention (CDC)) | up to 5 days | 
| Pain | Pain of the patient measured by NAS (Numeric analogue scale), VAS (Visual analogue scale), NRS (Numeric rating scale) and BPS (Behavioral pain scale) | up to 6 days | 
| Incidence of Delirium | Incidence of delirium measured accordingly by DSM IV (Diagnostic and statistical manual of mental disorders criteria for delirium), Nu-DESC (Nursing delirium screening scale), DDS (Delirium detection score), CAM (Confusion assessment method), CAM-ICU (Confusion assessment method for the ICU), DRS (Delirium rating scale) and ICDSC (Intensive care delirium screening checklist). | up to 6 days | 
| Incidence of Postoperative Cognitive Deficit (POCD) | Measurement of cognitive function by 5 tests out of CANTAB (Cambridge neuropsychological test automated battery) modeled by the ISPOCD1 study (International study of post-operative cognitive dysfunction), Stroop colour word test(SCWT) and verbal learning test(VLT) | up to 90 days after surgery | 
| Mobilisation | Duration and type of mobilisation | up to 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid and volume management, acid-base balance, goal-directed therapy, transoesophageal doppler