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

Phase 4

Completed

• Conditions: Hemodynamic Instability
• Interventions: Drug: Infusion Therapy

• Registration Number: NCT01117519
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Primary Completion: 2011-06
• Status Verified: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-15
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
unbalanced infusion solution	Infusion Therapy	-
balanced infusion solution compound	Infusion Therapy	-

Primary Outcome Measures

Name	Time	Method
Standard Base Excess	up to 2 days	After administration of 2 litres of study medication. In recovery room. On general ward.

Secondary Outcome Measures

Name	Time	Method
SID (strong ion difference)	up to 2 days	Change of the SID (strong ion difference) according to the stewart-approach of evalutation acid-base-dysbalances
Hemodynamic Stability	up to 6 days	Doses and duration of therapy with catecholamins, number and duration of hypotensive episodes
Fluid Loss of Drainage	up to 6 days	The quantity of fluids per day losing by drainage during the first three days after surgery
Discharge Criteria, Length of Hospital Stay	5 days up to hospital discharge	Time until fullfilling the hospital discharge criteria (measured by the postanesthesia discharge scoring system (PADSS)), and length of hospital stay
Organ Function/Dysfunction	up to 6 days	(Cumulative) frequency of postoperative organ dysfunctions (cerebral, cardiac, pulmonary, renal, gastrointestinal)
Incidence of Infections	up to 5 days	Perioperative Incidence of infections (according to the Centers of Disease and Prevention (CDC))
Pain	up to 6 days	Pain of the patient measured by NAS (Numeric analogue scale), VAS (Visual analogue scale), NRS (Numeric rating scale) and BPS (Behavioral pain scale)
Mobilisation	up to 6 days	Duration and type of mobilisation
Incidence of Delirium	up to 6 days	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).
Incidence of Postoperative Cognitive Deficit (POCD)	up to 90 days after surgery	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)

Trial Locations

Locations (1)

Dept. of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte, Charitéplatz 1; 🇩🇪 Berlin, Germany