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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01117519
First received: May 3, 2010
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Hemodynamic Instability
Drug: Infusion Therapy
Phase 4

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

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Standard Base Excess [ Time Frame: up to 2 days ] [ Designated as safety issue: Yes ]
    After administration of 2 litres of study medication. In recovery room. On general ward.


Secondary Outcome Measures:
  • SID (strong ion difference) [ Time Frame: up to 2 days ] [ Designated as safety issue: Yes ]
    Change of the SID (strong ion difference) according to the stewart-approach of evalutation acid-base-dysbalances

  • Hemodynamic Stability [ Time Frame: up to 6 days ] [ Designated as safety issue: Yes ]
    Doses and duration of therapy with catecholamins, number and duration of hypotensive episodes

  • Fluid Loss of Drainage [ Time Frame: up to 6 days ] [ Designated as safety issue: Yes ]
    The quantity of fluids per day losing by drainage during the first three days after surgery

  • Discharge Criteria, Length of Hospital Stay [ Time Frame: 5 days up to hospital discharge ] [ Designated as safety issue: Yes ]
    Time until fullfilling the hospital discharge criteria (measured by the postanesthesia discharge scoring system (PADSS)), and length of hospital stay

  • Organ Function/Dysfunction [ Time Frame: up to 6 days ] [ Designated as safety issue: Yes ]
    (Cumulative) frequency of postoperative organ dysfunctions (cerebral, cardiac, pulmonary, renal, gastrointestinal)

  • Incidence of Infections [ Time Frame: up to 5 days ] [ Designated as safety issue: Yes ]
    Perioperative Incidence of infections (according to the Centers of Disease and Prevention (CDC))

  • Pain [ Time Frame: up to 6 days ] [ Designated as safety issue: Yes ]
    Pain of the patient measured by NAS (Numeric analogue scale), VAS (Visual analogue scale), NRS (Numeric rating scale) and BPS (Behavioral pain scale)

  • Incidence of Delirium [ Time Frame: up to 6 days ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: up to 90 days after surgery ] [ Designated as safety issue: Yes ]
    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)

  • Mobilisation [ Time Frame: up to 6 days ] [ Designated as safety issue: No ]
    Duration and type of mobilisation


Enrollment: 40
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117519

Locations
Germany
Dept. of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte, Charitéplatz 1
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Claudia Spies, Prof., MD Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Claudia Spies, Prof. MD, Director of the Dept. of Anaesthesiology and Intensive Care Medicine, CVK, CCM, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01117519     History of Changes
Other Study ID Numbers: HIPSTER
Study First Received: May 3, 2010
Last Updated: November 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
fluid and volume management
acid-base balance
goal-directed therapy
transoesophageal doppler

ClinicalTrials.gov processed this record on April 17, 2014