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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014