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

Impact of a Balanced Infusion Solution Compound of 50% Crystalloid and 50% Colloid Versus an Unbalanced Infusion Solution of 100% Crystalloid Within a Goal-directed Hemodynamic Protocol on Acid-base Balance

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 Overview

• Status: Completed
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Drug: Infusion Therapy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Dept. of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte, Charitéplatz 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: unbalanced infusion solution	Drug: 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.
Active Comparator: balanced infusion solution compound	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Claudia Spies, Prof., MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 3, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (Estimate): May 5, 2010

Study Record Updates

• Last Update Posted (Estimate): November 16, 2011
• Last Update Submitted That Met QC Criteria: November 15, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: goal-directed therapy; acid-base balance; fluid and volume management; transoesophageal doppler
• Other Study ID Numbers: HIPSTER