Hemodynamic InstabilityPhase 4HIPSTERNCT01117519
Impact of Fluid Management Within a Goal-directed Hemodynamic Protocol on Acid-base Balance in Elective Trauma Surgery
A Phase 4 study testing Infusion Therapy in people with Hemodynamic Instability, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Infusion Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Anaesthesiology and Intensive Care Medicine, Campus Charité Mitte, Charitéplatz 1
Berlin, 10117
About this study
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
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
- Being tested
- Infusion Therapy
- Keywords
- fluid and volume management, acid-base balance, goal-directed therapy, transoesophageal doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| unbalanced infusion solution | Active comparator | Not described Receives: Drug: Infusion Therapy |
| balanced infusion solution compound | Active comparator | Not described Receives: Drug: Infusion Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Base Excess
After administration of 2 litres of study medication. In recovery room. On general ward.
Measured: up to 2 days
Secondary outcomes (10)
SID (strong ion difference)
Change of the SID (strong ion difference) according to the stewart-approach of evalutation acid-base-dysbalances
Measured: up to 2 days
Hemodynamic Stability
Doses and duration of therapy with catecholamins, number and duration of hypotensive episodes
Measured: up to 6 days
Fluid Loss of Drainage
The quantity of fluids per day losing by drainage during the first three days after surgery
Measured: 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
Measured: 5 days up to hospital discharge
Organ Function/Dysfunction
(Cumulative) frequency of postoperative organ dysfunctions (cerebral, cardiac, pulmonary, renal, gastrointestinal)
Measured: up to 6 days
Incidence of Infections
Perioperative Incidence of infections (according to the Centers of Disease and Prevention (CDC))
Measured: 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)
Measured: 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).
Measured: 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)
Measured: up to 90 days after surgery
Mobilisation
Duration and type of mobilisation
Measured: up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, Prof., MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117519
- Sponsor's protocol ID
- HIPSTER
- Acronym
- HIPSTER
- Status last verified
- Nov 2011
- First submitted
- 3 May 2010
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01117519
- Acronym / sponsor ID
- HIPSTER / HIPSTER
- Conditions
- Hemodynamic Instability
- Keywords
- fluid and volume management, acid-base balance, goal-directed therapy, transoesophageal doppler
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unbalanced infusion solution | Active comparator | Drug: Infusion Therapy |
| balanced infusion solution compound | Active comparator | Drug: Infusion Therapy |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infusion TherapyBased 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. | Drug | balanced infusion solution compound, unbalanced infusion solution |
Primary outcome
Standard Base Excess
Time frame: up to 2 days
After administration of 2 litres of study medication. In recovery room. On general ward.
10 secondary outcomes
SID (strong ion difference)
Time frame: up to 2 days
Hemodynamic Stability
Time frame: up to 6 days
Fluid Loss of Drainage
Time frame: up to 6 days
Discharge Criteria, Length of Hospital Stay
Time frame: 5 days up to hospital discharge
Organ Function/Dysfunction
Time frame: up to 6 days
Incidence of Infections
Time frame: up to 5 days
Pain
Time frame: up to 6 days
Incidence of Delirium
Time frame: up to 6 days
Incidence of Postoperative Cognitive Deficit (POCD)
Time frame: up to 90 days after surgery
Mobilisation
Time frame: up to 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, Prof., MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infusion Therapy in people with Hemodynamic Instability, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Base Excess (time frame: up to 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011.