Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels

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.

Study Overview

• Status: Completed
• Conditions: Fluid Overload; Perioperative/Postoperative Complications; Hemoglobin H
• Intervention / Treatment: Other: GDT

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg/Vorpommern
    • Rostock, Mecklenburg/Vorpommern, Germany, 18057
      • University of Rostock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing major abdominal surgery

Description

Inclusion Criteria:

• major abdominal surgery
• informed consent

Exclusion Criteria:

• violation of study protocol

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GDT Group; receives goal-directed therapy	Other: GDT; individualized fluid therapy
Not GDT Group; receives no individualized goal-directed therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of perioperative fluid therapy on hemoglobin levels	Influence of perioperative fluid therapy on hemoglobin levels	during surgery
Influence of perioperative fluid therapy on Methemoglobin levels	Influence of perioperative fluid therapy on Methemoglobin levels	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of perioperative fluid therapy on changes in lactate	Influence of perioperative fluid therapy on changes in lactate	during surgery
Influence of perioperative fluid therapy on SvO2	Influence of perioperative fluid therapy on SvO2	during surgery

Collaborators and Investigators

• Sponsor: University of Rostock
• Investigators: Principal Investigator: Thomas Mencke, Prof., University of Rostock

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: perioperative; fluid therapy; hemodilution
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: A 2017-0073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No