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NCT03220620 Clinical Trial

Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels

Perioperative/Postoperative Complications Clinical Trial

Official title:
Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels in Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03220620
Other study ID # A 2017-0073
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 14, 2017
Est. completion date January 1, 2020

Study information
Verified date November 2020
Source University of Rostock
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). Patients undergoing major abdominal surgery will be included into the study.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date January 1, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - major abdominal surgery - informed consent Exclusion Criteria: - violation of study protocol

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• GDT
individualized fluid therapy

Locations
Country Name City State
Germany University of Rostock Rostock Mecklenburg/Vorpommern

Sponsors (1)
Lead Sponsor Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Influence of perioperative fluid therapy on hemoglobin levels Influence of perioperative fluid therapy on hemoglobin levels during surgery
Primary Influence of perioperative fluid therapy on Methemoglobin levels Influence of perioperative fluid therapy on Methemoglobin levels during surgery
Secondary Influence of perioperative fluid therapy on changes in lactate Influence of perioperative fluid therapy on changes in lactate during surgery
Secondary Influence of perioperative fluid therapy on SvO2 Influence of perioperative fluid therapy on SvO2 during surgery
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