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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| unbalanced infusion solution | Active Comparator |
| |
| balanced infusion solution compound | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion Therapy | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, Prof., MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte, Charitéplatz 1 | Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D018718 | Home Infusion Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D006699 | Home Care Services |
| D003153 | Community Health Services |
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|
| 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 |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |