Perioperative/Postoperative ComplicationsNCT03220620
Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels
An observational study of Perioperative/Postoperative Complications and Fluid Overload, run by University of Rostock at 1 site in Germany.
Trial summary
The objective of the study is to evaluate influence of perioperative fluid therapy on Methemoglobin levels, and to changes in hemoglobin. Further, changes in Methemoglobin will be related to metabolic signs of oxidative stress (changes in blood lactate). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Perioperative/Postoperative Complications, Fluid Overload, Hemoglobin H
- What is being tested?
- GDT
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jul 2017to 1 Jan 2020
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing major abdominal surgery
Who may be able to join
- major abdominal surgery
- informed consent
Who cannot join
- violation of study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels in Major Abdominal Surgery
The objective of the study is to evaluate influence of perioperative fluid therapy on Methemoglobin levels, and to changes in hemoglobin. Further, changes in Methemoglobin will be related to metabolic signs of oxidative stress (changes in blood lactate). Patients undergoing major abdominal surgery will be included into the study.
Read the detailed description
Increasing plasma volume by intravenous administration of crystalloid and/or colloid solutions may cause a relative reduction in hemoglobin (Hb) concentration, a situation that is termed 'dilutional anemia'. Such hemodilution may lead to an iatrogenic reduction in oxygen-carrying capacity and the development of organ dysfunction. Paradoxically, large amounts of fluids that are administered with the aim of increasing oxygen delivery (DO2), as is frequently done as part of perioperative goal-directed therapy; this may lead to an actual decrease in the DO2 due to a decrease in Hb concentration.
Another potential parameter that may reflect the development of dilutional anemia is methemoglobin (MetHb), a form of Hb with reduced ability for oxygen binding. Experimental studies showed that dilutional anemia may lead to up-regulation of perivascular nitric oxide synthase (NOS) and increase NOS-derived nitric oxide (NO) leading to local vasodilation and oxidization of Hb to MetHb. MetHb may potentially serve as a biomarker of 'anemic stress' associated with reduced tissue perfusion during acute hemodilution.
- Being tested
- GDT
- Keywords
- fluid therapy, perioperative, hemodilution
- Medical subject headings
- Postoperative Complications, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDTOther
individualized fluid therapy
| Study group | Role | What they receive |
|---|---|---|
| GDT Group | receives goal-directed therapy Receives: Other: GDT | |
| Not GDT Group | receives no individualized goal-directed therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of perioperative fluid therapy on hemoglobin levels
Influence of perioperative fluid therapy on hemoglobin levels
Measured: during surgery
Influence of perioperative fluid therapy on Methemoglobin levels
Influence of perioperative fluid therapy on Methemoglobin levels
Measured: during surgery
Secondary outcomes (2)
Influence of perioperative fluid therapy on changes in lactate
Influence of perioperative fluid therapy on changes in lactate
Measured: during surgery
Influence of perioperative fluid therapy on SvO2
Influence of perioperative fluid therapy on SvO2
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start14 Jul 2017
- Primary completion31 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative/Postoperative ComplicationsStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Mencke, University of Rostock
- Investigators
- Thomas Mencke, Prof., Principal investigator, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220620
- Sponsor's protocol ID
- A 2017-0073
- Status last verified
- Nov 2020
- First submitted
- 14 Jul 2017
- Last updated
- 3 Nov 2020
- 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 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03220620
- Acronym / sponsor ID
- A 2017-0073
- Keywords
- fluid therapy, perioperative, hemodilution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 18 Jul 2017 (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.
The objective of the study is to evaluate influence of perioperative fluid therapy on Methemoglobin levels, and to changes in hemoglobin. Further, changes in Methemoglobin will be related to metabolic signs of oxidative stress (changes in blood lactate). Patients undergoing major abdominal surgery will be included into the study.
Detailed description
Increasing plasma volume by intravenous administration of crystalloid and/or colloid solutions may cause a relative reduction in hemoglobin (Hb) concentration, a situation that is termed 'dilutional anemia'. Such hemodilution may lead to an iatrogenic reduction in oxygen-carrying capacity and the development of organ dysfunction. Paradoxically, large amounts of fluids that are administered with the aim of increasing oxygen delivery (DO2), as is frequently done as part of perioperative goal-directed therapy; this may lead to an actual decrease in the DO2 due to a decrease in Hb concentration.
Another potential parameter that may reflect the development of dilutional anemia is methemoglobin (MetHb), a form of Hb with reduced ability for oxygen binding. Experimental studies showed that dilutional anemia may lead to up-regulation of perivascular nitric oxide synthase (NOS) and increase NOS-derived nitric oxide (NO) leading to local vasodilation and oxidization of Hb to MetHb. MetHb may potentially serve as a biomarker of 'anemic stress' associated with reduced tissue perfusion during acute hemodilution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDT Group | – | Other: GDTreceives goal-directed therapy |
| Not GDT Group | – | –receives no individualized goal-directed therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing major abdominal surgery
Key inclusion criteria (2 listed)
- major abdominal surgery
- informed consent
Key exclusion criteria (1 listed)
- violation of study protocol
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 |
|---|---|---|
| GDTindividualized fluid therapy | Other | GDT Group |
Primary outcome
Influence of perioperative fluid therapy on hemoglobin levels
Time frame: during surgery
Influence of perioperative fluid therapy on hemoglobin levels
Influence of perioperative fluid therapy on Methemoglobin levels
Time frame: during surgery
Influence of perioperative fluid therapy on Methemoglobin levels
2 secondary outcomes
Influence of perioperative fluid therapy on changes in lactate
Time frame: during surgery
Influence of perioperative fluid therapy on SvO2
Time frame: during surgery
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 3 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Thomas Mencke, Prof. principal investigator
University of Rostock
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 Perioperative/Postoperative Complications and Fluid Overload, run by University of Rostock 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 1 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 3 Nov 2020. 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?
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?
Influence of perioperative fluid therapy on hemoglobin levels (time frame: during surgery). The study lists 2 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 3 Nov 2020.