Diaphragm KineticsNCT04889235
Diaphragm Kinetics Following Hepatic Resection
An observational study of Diaphragm Kinetics and Sarcopenia, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Sarcopenia is associated with reduced pulmonary function in healthy adults, as well as with increased risk of pneumonia following abdominal surgery. Consequentially, postoperative pneumonia prolongs hospital admission, and increases in-hospital mortality following a range of surgical interventions. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diaphragm Kinetics, Sarcopenia, Muscle Wasting
- What is being tested?
- Major liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2020to 1 Nov 2022
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- Adult, Older adult
Study population: This study will entail a prospective observational single center study, analyzing 44 consecutive patients undergoing major liver resection, 22 patients will be sarcopenic, 22 will be non-sarcopenic
Who may be able to join
- Patients between 18- and 80 years old
- Patients undergoing elective Major hepatic resection for the treatment of malignant disease.
- Patients with all tumor Stages (TNM classification).
- Only patients undergoing Major hepatic resection.
Who cannot join
- American Anesthesiology Association (ASA)-classification IV or higher
- Liver cirrhosis Child grade B or higher
- End stage renal disease requiring dialysis
- Severe heart disease New York Heart Association class IV
- Pulmonary condition:
- Chronic obstructive pulmonary disease (COPD)
Show all 13Show fewer
- Asthma
- History of pulmonary surgery
- History of pulmonary embolism
- Smoking
- Pleural effusion occupying more than 1/3 of the pleural space
- Neurological disorders leading to paraparesis of the upper or lower limbs
- Known muscular dystrophic disorders
Trial locations and contacts
1 site in 1 country.
Steven Olde Damink, Prof. contact
Germany1 site, 1 recruiting
- Recruiting
Uniklinik Aachen
Aachen, North Rhine-Westphalia, 52074
Gregory van der Kroft, M.D., gvanderkroft@ukaachen.de
About this study
Official title: Diaphragm Kinetics Following Hepatic Resection, Comparison Between a Sarcopenic and Non-sarcopenic Cohort.
Sarcopenia is associated with reduced pulmonary function in healthy adults, as well as with increased risk of pneumonia following abdominal surgery. Consequentially, postoperative pneumonia prolongs hospital admission, and increases in-hospital mortality following a range of surgical interventions. Little is known about the function of the diaphragm in the context of sarcopenia and wasting disorders or how its function is influenced by abdominal surgery. Liver surgery induces reactive pleural effusion in most patients, compromising post-operative pulmonary function.
Hypotheses:
Read more
- Both major hepatic resection and sarcopenia have a measurable impact on diaphragm function.
- Sarcopenia is associated with reduced preoperative diaphragm function, and that patients with reduced preoperative diaphragm function show a greater decline and reduced recovery of diaphragm function following major hepatic resection.
Goals:
The primary goal of this study is to evaluate whether sarcopenic patients have a reduced diaphragm function prior to major liver resection compared to non-sarcopenic patients, and to evaluate whether sarcopenic patients show a greater reduction in respiratory muscle function following major liver resection when compared to non-sarcopenic patients.
Methods and analysis:
Trans-costal B-mode, M-mode ultrasound and speckle tracking imaging will be used to assess diaphragm function perioperatively in patients undergoing major hepatic resection starting one day prior to surgery and up to thirty days after surgery. In addition, rectus abdominis and quadriceps femoris muscles thickness will be measured using ultrasound to measure sarcopenia, and pulmonary function will be measured using a hand-held bedside spirometer. Muscle mass will be determined preoperatively using CT-muscle volumetry of abdominal muscle and adipose tissue at the third lumbar vertebra level (L3). Muscle function will be assessed using handgrip strength and physical condition will be measured with a short physical performance battery (SPPB). A rectus abdominis muscle biopsy will be taken intraoperatively to measure proteolytic and mitochondrial activity as well as inflammation and redox status. Systemic inflammation and sarcopenia biomarkers will be assessed in serum acquired perioperatively.
- Conditions
- Diaphragm Kinetics, Sarcopenia, Muscle Wasting, Liver Resection
- Being tested
- Major liver resection
- Medical subject headings
- Sarcopenia, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major liver resectionProcedure or surgery
All patients undergo Major hepatic resection, differences between sarcopenia and no-sarcopenia groups will be observed
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenia | Sarcopenia will be defined as either low estimated muscle mass measured by CT-muscle volumetry or reduced muscle function measured by handgrip strength, or reduced physical condition as defined by the European Working Group on Sarcopenia in Older People (EWGSOP) Receives: Procedure: Major liver resection | |
| No Sarcopenia | Sarcopenia will be defined as either low estimated muscle mass measured by CT-muscle volumetry or reduced muscle function measured by handgrip strength, or reduced physical condition as defined by the European Working Group on Sarcopenia in Older People (EWGSOP) Receives: Procedure: Major liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm kinetics
Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.
Diaphragm muscle kinetics will be evaluated using the following outcome value.
-Deformation%
Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Measured: Day 1
Diaphragm kinetics
Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.
Diaphragm muscle kinetics will be evaluated using the following value.
-Deformation velocity (in cm/second)
Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Measured: Day 1
Diaphragm kinetics
Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.
Diaphragm muscle kinetics will be evaluated using the following value.
-Fractional thickening (thickening coefficient)
Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Measured: Day 1
Diaphragm kinetics
Comparing diaphragm and abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.
Diaphragm muscle kinetics will be evaluated using the following value.
-Range of DIA (in cm)
Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Measured: Day 1
Abdominal muscle kinetics
Primary outcome:
Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.
Abdominal muscle kinetics will be evaluated using the following value.
-Thickness (in cm)
Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Measured: Day 1
Abdominal muscle kinetics
Primary outcome:
Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.
Abdominal muscle kinetics will be evaluated using the following value.
-Deformation%
Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Measured: Day 1
Abdominal muscle kinetics
Primary outcome:
Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.
Abdominal muscle kinetics will be evaluated using the following value.
-Deformation velocity (in cm/second)
Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Measured: Day 1
Secondary outcomes (7)
Diaphragm kinetics
Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.
Diaphragm muscle kinetics will be evaluated using the following value.
-Deformation%
Differences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
Measured: 30 days
Diaphragm kinetics
Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.
Diaphragm muscle kinetics will be evaluated using the following value.
-Deformation velocity (in cm/second)
Differences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
Measured: 30 days
Diaphragm kinetics
Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.
Diaphragm muscle kinetics will be evaluated using the following value.
-Fractional thickening (thickening coefficient)
Differences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
Measured: 30 days
Diaphragm kinetics
Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.
Diaphragm muscle kinetics will be evaluated using the following value.
-Range of DIA (in cm)
Differences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
Measured: 30 days
Abdominal muscle kinetics
Evaluating longitudinal changes in abdominal muscle kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.
Abdominal muscle kinetics will be evaluated using the following value.
-Thickness (in cm)
Differences in mean values and standard deviations of individual values describing abdominal muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
Measured: 30 days
Abdominal muscle kinetics
Evaluating longitudinal changes in abdominal muscle kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.
Abdominal muscle kinetics will be evaluated using the following value.
-Deformation%
Differences in mean values and standard deviations of individual values describing abdominal muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
Measured: 30 days
Abdominal muscle kinetics
Evaluating longitudinal changes in abdominal muscle kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.
Abdominal muscle kinetics will be evaluated using the following value.
-Deformation velocity (in cm/second)
Differences in mean values and standard deviations of individual values describing abdominal muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Apr 2020
- Primary completion1 May 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm KineticsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory van der Kroft, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889235
- Sponsor's protocol ID
- EK 309-18
- Status last verified
- May 2021
- First submitted
- 21 Oct 2020
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Kinetics Following Hepatic Resection, Comparison Between a Sarcopenic and Non-sarcopenic Cohort.
- ClinicalTrials.gov ID
- NCT04889235
- Acronym / sponsor ID
- EK 309-18
- Conditions
- Diaphragm Kinetics, Sarcopenia, Muscle Wasting, Liver Resection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 17 May 2021 (actual)
- 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.
Sarcopenia is associated with reduced pulmonary function in healthy adults, as well as with increased risk of pneumonia following abdominal surgery. Consequentially, postoperative pneumonia prolongs hospital admission, and increases in-hospital mortality following a range of surgical interventions. Little is known about the function of the diaphragm in the context of sarcopenia and wasting disorders or how its function is influenced by abdominal surgery. Liver surgery induces reactive pleural effusion in most patients, compromising post-operative pulmonary function.
Hypotheses:
- Both major hepatic resection and sarcopenia have a measurable impact on diaphragm function.
- Sarcopenia is associated with reduced preoperative diaphragm function, and that patients with reduced preoperative diaphragm function show a greater decline and reduced recovery of diaphragm function following major hepatic resection.
Goals:
The primary goal of this study is to evaluate whether sarcopenic patients have a reduced diaphragm function prior to major liver resection compared to non-sarcopenic patients, and to evaluate whether sarcopenic patients show a greater reduction in respiratory muscle function following major liver resection when compared to non-sarcopenic patients.
Methods and analysis:
Trans-costal B-mode, M-mode ultrasound and speckle tracking imaging will be used to assess diaphragm function perioperatively in patients undergoing major hepatic resection starting one day prior to surgery and up to thirty days after surgery. In addition, rectus abdominis and quadriceps femoris muscles thickness will be measured using ultrasound to measure sarcopenia, and pulmonary function will be measured using a hand-held bedside spirometer. Muscle mass will be determined preoperatively using CT-muscle volumetry of abdominal muscle and adipose tissue at the third lumbar vertebra level (L3). Muscle function will be assessed using handgrip strength and physical condition will be measured with a short physical performance battery (SPPB). A rectus abdominis muscle biopsy will be taken intraoperatively to measure proteolytic and mitochondrial activity as well as inflammation and redox status. Systemic inflammation and sarcopenia biomarkers will be assessed in serum acquired perioperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenia | – | Procedure: Major liver resectionSarcopenia will be defined as either low estimated muscle mass measured by CT-muscle volumetry or reduced muscle function measured by handgrip strength, or reduced physical condition as defined by the European Working Group on Sarcopenia in Older People (EWGSOP) |
| No Sarcopenia | – | Procedure: Major liver resectionSarcopenia will be defined as either low estimated muscle mass measured by CT-muscle volumetry or reduced muscle function measured by handgrip strength, or reduced physical condition as defined by the European Working Group on Sarcopenia in Older People (EWGSOP) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will entail a prospective observational single center study, analyzing 44 consecutive patients undergoing major liver resection, 22 patients will be sarcopenic, 22 will be non-sarcopenic
Key inclusion criteria (4 listed)
- Patients between 18- and 80 years old
- Patients undergoing elective Major hepatic resection for the treatment of malignant disease.
- Patients with all tumor Stages (TNM classification).
- Only patients undergoing Major hepatic resection.
Key exclusion criteria (13 listed)
- American Anesthesiology Association (ASA)-classification IV or higher
- Liver cirrhosis Child grade B or higher
- End stage renal disease requiring dialysis
- Severe heart disease New York Heart Association class IV
- Pulmonary condition:
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 |
|---|---|---|
| Major liver resectionAll patients undergo Major hepatic resection, differences between sarcopenia and no-sarcopenia groups will be observed | Procedure or surgery | No Sarcopenia, Sarcopenia |
Primary outcome
Diaphragm kinetics
Time frame: Day 1
Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound. Diaphragm muscle kinetics will be evaluated using the following outcome value. -Deformation% Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Diaphragm kinetics
Time frame: Day 1
Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound. Diaphragm muscle kinetics will be evaluated using the following value. -Deformation velocity (in cm/second) Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Diaphragm kinetics
Time frame: Day 1
Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound. Diaphragm muscle kinetics will be evaluated using the following value. -Fractional thickening (thickening coefficient) Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Diaphragm kinetics
Time frame: Day 1
Comparing diaphragm and abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound. Diaphragm muscle kinetics will be evaluated using the following value. -Range of DIA (in cm) Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Abdominal muscle kinetics
Time frame: Day 1
Primary outcome: Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound. Abdominal muscle kinetics will be evaluated using the following value. -Thickness (in cm) Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Abdominal muscle kinetics
Time frame: Day 1
Primary outcome: Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound. Abdominal muscle kinetics will be evaluated using the following value. -Deformation% Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Abdominal muscle kinetics
Time frame: Day 1
Primary outcome: Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound. Abdominal muscle kinetics will be evaluated using the following value. -Deformation velocity (in cm/second) Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
7 secondary outcomes
Diaphragm kinetics
Time frame: 30 days
Diaphragm kinetics
Time frame: 30 days
Diaphragm kinetics
Time frame: 30 days
Diaphragm kinetics
Time frame: 30 days
Abdominal muscle kinetics
Time frame: 30 days
Abdominal muscle kinetics
Time frame: 30 days
Abdominal muscle kinetics
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Individual participant dataSharing planned: No
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.
Steven Olde Damink, Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Kinetics and Sarcopenia, run by RWTH Aachen University 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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 17 May 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregory van der Kroft, M.D. (+492418089501, gvanderkroft@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm kinetics (time frame: Day 1). The study lists 7 primary outcomes in all. 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 17 May 2021.