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Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels

NCT ID: NCT03220620

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-14

Study Completion Date

2020-01-01

Brief Summary

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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

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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.

Conditions

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Perioperative/Postoperative Complications Fluid Overload Hemoglobin H

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GDT Group

receives goal-directed therapy

GDT

Intervention Type OTHER

individualized fluid therapy

Not GDT Group

receives no individualized goal-directed therapy

No interventions assigned to this group

Interventions

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GDT

individualized fluid therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* major abdominal surgery
* informed consent

Exclusion Criteria

* violation of study protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rostock

OTHER

Sponsor Role lead

Responsible Party

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Thomas Mencke

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Mencke, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Rostock

Locations

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University of Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

Other Identifiers

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A 2017-0073

Identifier Type: -

Identifier Source: org_study_id