Trial document




drksid header

  DRKS00016661

Trial Description

start of 1:1-Block title

Title

The influence of oral supplement nutrition for geriatric patients with fractures of the proximal femur and malnutrition

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The study is aimed at geriatric malnourished patients with fractures close to the hip joint.

Up to now, the focus has been on the surgical treatment of fractures close to the hip joint and attempts have been made to compensate for any malnutrition with the normal food on offer. We know from other medical fields that malnourished patients often have to be treated in hospital for longer periods of time. This can be caused by wound healing disorders, infections and, in some cases, the associated re-operations. In addition, we know that it is good for planned operations if malnutrition is treated beforehand in order to reduce these risks. For patients with fractures that have occurred as a result of a fall and require a quick operation, it is of course not possible to treat malnutrition before the operation - this would take too long. However, we would like to investigate in this study whether short-term therapy still has an advantage for these patients. We hope that the planned clinical trial will carry out:
- faster physical recovery with a shorter stay in the clinic
- the reduction of possible subsequent operations due to wound infections or wound healing disorders
- a lower incidence of illnesses such as those frequently occurring during prolonged hospital stays and bed-ridden periods (e. g. bladder infection and pneumonia, pressure sores)
- to find laboratory parameters and examination methods that help us to identify patients who are particularly susceptible to complications and who can be helped by supplementary food already when they are admitted to hospital
- to find genes and their interactions that explain this susceptibility to complications in malnutrition, in order to develop even better therapeutic concepts for the future.
The supplementary food used has already been approved as a dietary supplement for years and is now to be tested for its benefits in connection with these disease.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The aim of the project is to investigate the influence of a protein-rich supplementary diet on the early postoperative course in the collective of geriatric patients. Particularly in the group of geriatric patients, the risk and incidence of malnutrition are significantly increased. From other medical areas such as tumor surgery, we know that malnutrition is a risk for prolonged hospital stays. The longer stays can be caused by wound healing disorders, infections or prolonged mobilization phases accompanied by physiotherapy. Initial studies have shown that pre-existent malnutrition makes our already preoperatively vulnerable patients more susceptible to complications and thus contributes to delayed mobilization and increased infection rates. For the collective of elective patients, we know that compensation for existing malnutrition prior to surgery leads to a reduction in complications and an improvement in outcome. For obvious reasons, we do not have this possibility in the field of fracture treatment, and so the question arises in the field of trauma surgery as to whether short-term intervention can also benefit these patients. As geriatric patients, in particular, are affected by malnutrition, the study will refer to this group of patients. Due to demographic change, a significant increase in geriatric malnourished patients is to be expected, which lends topicality to this question. To clarify the hypothesis, a randomized pilot study with a control and an intervention group will be designed. The intervention group will receive an oral nutritional supplement 2x daily as an intermediate diet. Since so far only one trend for an advantage of this intervention could be shown in individual studies with small collectives independent of the existing nutritional status, a possible dilution of the results by normal or non-geriatric patients should be avoided. Since in the entirety of accident patients, especially the group with proximal femoral fractures is affected by a considerable incision in life, this patient collective will be investigated. Especially in this patient group, there is the great advantage that all patients can be fully mobilized without postoperative partial loading and are therefore easily comparable. The short-term benefits of inpatient intervention are considered. Therefore, faster mobilization, fewer wound healing disorders and infections, less muscle loss and a reduced stay time of the intervention group compared to the control group were assessed as positive outcomes.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00016661
  •   2019/01/31
  •   [---]*
  •   yes
  •   Approved
  •   A 2017-0093, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   S72.0 -  Fracture of neck of femur
  •   S72.1 -  Pertrochanteric fracture
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   patients with supplemental oral protein nutrition two times daily 30 g during hospital stay
  •   patients with placebo
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

For discharge, the current physical status is checked again and a BIA (Bioelectrical impedance analysis) measurement, hand strength measurement, laboratory parameters and the mobilisation achieved are recorded and compared with the values for admission and control group. In addition, complications (infections, wound healing disorders, etc.) are recorded on the basis of the medical records.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Compliance to take supplemental oral nutrition

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/02/01
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   70   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

fracture close to the hip, malnutrition

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

pathological fracture, pneumonia at administration

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsmedizin Rostock Chirurgische Klinik und Poliklinik Abteilung für Unfall-, Hand- und Wiederherstellungschirurgie
    • Ms.  Dr. med. Dipl. Inf.  Steffi  Falk 
    • Schillingalle 35
    • 18057  Rostock
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsmedizin Rostock Chirurgische Klinik und Poliklinik Abteilung für Unfall-, Hand- und Wiederherstellungschirurgie
    • Ms.  Dr. med. Dipl. Inf.  Steffi  Falk 
    • Schillingalle 35
    • 18057  Rostock
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsmedizin Rostock Chirurgische Klinik und Poliklinik Abteilung für Unfall-, Hand- und Wiederherstellungschirurgie
    • Ms.  Dr. med. Dipl. Inf.  Steffi  Falk 
    • Schillingalle 35
    • 18057  Rostock
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsmedizin Rostock Chirurgische Klinik und Poliklinik Abteilung für Unfall-, Hand- und Wiederherstellungschirurgie
    • Ms.  Dr. med. Dipl. Inf.  Steffi  Falk 
    • Schillingalle 35
    • 18057  Rostock
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.