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

Charité University Medicine Berlin

Status and phase

Completed

Phase 4

Conditions

Hemodynamic Instability

Treatments

Drug: Infusion Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01117519

HIPSTER

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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)