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

NCT ID: NCT01117519

Last Updated: 2011-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-11-30

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.

Conditions

Hemodynamic Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

unbalanced infusion solution

Group Type: ACTIVE_COMPARATOR

Infusion Therapy

Intervention Type: 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.

balanced infusion solution compound

Group Type: ACTIVE_COMPARATOR

Infusion Therapy

Intervention Type: 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.

Interventions

Infusion Therapy

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Prof. MD, Director of the Dept. of Anaesthesiology and Intensive Care Medicine, CVK, CCM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Dept. of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte, Charitéplatz 1

Berlin, , Germany

Countries

Germany

Other Identifiers

HIPSTER

Identifier Type: -

Identifier Source: org_study_id