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

NCT01117519 | Completed Phase 4

• 1 other identifier: HIPSTER
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability

Keywords

fluid and volume management; acid-base balance; goal-directed therapy; transoesophageal doppler

Outcome Measures

Primary Outcomes (1)

• Standard Base Excess

  After administration of 2 litres of study medication. In recovery room. On general ward.

  up to 2 days

Secondary Outcomes (10)

• SID (strong ion difference)

  up to 2 days

• Hemodynamic Stability

  up to 6 days

• Fluid Loss of Drainage

  up to 6 days

• Discharge Criteria, Length of Hospital Stay

  5 days up to hospital discharge

• Organ Function/Dysfunction

  up to 6 days

Study Arms (2)

unbalanced infusion solution

ACTIVE COMPARATOR

Drug: Infusion Therapy

balanced infusion solution compound

ACTIVE COMPARATOR

Drug: Infusion Therapy

Interventions

Infusion Therapy DRUG

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.

balanced infusion solution compound; unbalanced infusion solution

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Dept. of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte, Charitéplatz 1

Berlin, 10117, Germany

Location

MeSH Terms

Interventions

Home Infusion Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Claudia Spies, Prof., MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD, Director of the Dept. of Anaesthesiology and Intensive Care Medicine, CVK, CCM

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 16, 2011

Record last verified: 2011-11

Locations

DE (1)