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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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.
Dept. of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte, Charitéplatz 1
Berlin, Germany
Standard Base Excess
After administration of 2 litres of study medication. In recovery room. On general ward.
Time frame: up to 2 days
SID (strong ion difference)
Change of the SID (strong ion difference) according to the stewart-approach of evalutation acid-base-dysbalances
Time frame: up to 2 days
Hemodynamic Stability
Doses and duration of therapy with catecholamins, number and duration of hypotensive episodes
Time frame: up to 6 days
Fluid Loss of Drainage
The quantity of fluids per day losing by drainage during the first three days after surgery
Time frame: 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
Time frame: 5 days up to hospital discharge
Organ Function/Dysfunction
(Cumulative) frequency of postoperative organ dysfunctions (cerebral, cardiac, pulmonary, renal, gastrointestinal)
Time frame: up to 6 days
Incidence of Infections
Perioperative Incidence of infections (according to the Centers of Disease and Prevention (CDC))
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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).
Time frame: 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)
Time frame: up to 90 days after surgery
Mobilisation
Duration and type of mobilisation
Time frame: up to 6 days