Changes in Body Water During Surgery

NCT05272540 | Completed

• 1 other identifier: BIA
• Study Type: observational
• Target: 1,696
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fluid is added during anesthesia and surgery to maintain and balance the dynamic hemodynamics during a surgical procedure. Excess fluid after surgery is strongly correlated with morbidity and mortality. Bioelectrical impedance analysis (BIA) measures the total body water. Increased knowledge of the degree of preoperative hydration and the perioperative course can contribute to active treatment and reduced morbidity. Women and men ≥18 years of age who are to undergo gynecological or urological operations are included in the study. The purpose is to analyze the baseline status of the degree of hydration measured as the total body water and its components, and to monitor changes in these during a postoperative course, and to look for connections between these parameters and patient characteristics, laboratory data, type of surgery, type of anesthesia, care period and onset of postoperative symptoms and complications.

Conditions

Postoperative Complications; Bioelectrical Impedance; Hospital Stay; Hydration

Outcome Measures

Primary Outcomes (1)

• Perioperative change in hydration

  Degree of hydration measured by bioelectrical impedance analysis

  Preoperative on day of surgery and postoperative daily during hospital stay up to 30 days after surgery

Secondary Outcomes (7)

• Postoperative symptoms

  Day of surgery until 8 week postoperatively

• Postoperative complications

  Day of surgery until 8 week postoperatively

• Duration of hospital care

  Day of surgery until 8 weeks postoperatively

• Precision of bioimpedance analysis of total body water in test-retest measurements.

  Two repeated measurements preoperatively (less than 10 minutes)

• Precision of bioimpedance analysis of intracellular water in test-retest measurements.

  Two repeated measurements preoperatively (less than 10 minutes)

Study Arms (2)

Day case surgery

Adult patients who are operated on as outpatients in day surgery. Treatment and care follow clinical routine. Weighing on a scales measuring bioelectrical impedance data before and after the surgery is added.

In patient surgery

Adult patients who are operated on as inpatients in hospital care. Treatment and care follow clinical routine. Weighing on a scales measuring bioelectrical impedance data before the surgery and every morning during hospital stay is added.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women and men ≥18 years of age who are to undergo planned gynecological or urological operations under general anesthesia, regional anesthesia, sedation or local anesthesia at the University Hospital, Linköping, Sweden.

You may qualify if:

• Women and men ≥18 years of age who are to undergo gynecological or urological operations under general anesthesia, regional anesthesia, sedation or local anesthesia
• Women and men who have given informed consent to participate in the study

You may not qualify if:

• Patients with pacemakers or implanted defibrillators (ICDs)
• Pregnant women with intrauterine viable pregnancy where the pregnancy should not be terminated
• Disabled patients who can not stand on the scales
• Patients with one hand or foot missing
• Patients on dialysis due to kidney failure
• Patients who are unable to understand the meaning of the study and provide informed consent

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Related Publications (1)

• Asklof M, Kjolhede P, Wodlin NB, Nilsson L. Bioelectrical impedance analysis; a new method to evaluate lymphoedema, fluid status, and tissue damage after gynaecological surgery - A systematic review. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:111-119. doi: 10.1016/j.ejogrb.2018.06.024. Epub 2018 Jun 18.

  PMID: 29933195 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Preben Kjölhede, Prof.

  University Hospital, Linköing

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 9, 2022
• Study Start: September 13, 2016
• Primary Completion: August 19, 2021
• Study Completion: December 31, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share