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

Hemodynamic Instability Clinical Trial

— HIPSTER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117519
• Other study ID #: HIPSTER
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2010
• Last updated: November 15, 2011
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

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.

Locations

Country	Name	City	State
Germany	Dept. of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte, Charitéplatz 1	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard Base Excess	After administration of 2 litres of study medication. In recovery room. On general ward.	up to 2 days	Yes
Secondary	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	Yes
Secondary	Hemodynamic Stability	Doses and duration of therapy with catecholamins, number and duration of hypotensive episodes	up to 6 days	Yes
Secondary	Fluid Loss of Drainage	The quantity of fluids per day losing by drainage during the first three days after surgery	up to 6 days	Yes
Secondary	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	Yes
Secondary	Organ Function/Dysfunction	(Cumulative) frequency of postoperative organ dysfunctions (cerebral, cardiac, pulmonary, renal, gastrointestinal)	up to 6 days	Yes
Secondary	Incidence of Infections	Perioperative Incidence of infections (according to the Centers of Disease and Prevention (CDC))	up to 5 days	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Mobilisation	Duration and type of mobilisation	up to 6 days	No