Trial Outcomes & Findings for Using Electrical Bioimpedance Assessments to Estimate Perioperative Total Body Water and Postoperative Fluid Need (NCT NCT02200055)

NCT ID: NCT02200055

Last Updated: 2018-08-28

Results Overview

Bioimpedance assessment measurements were recorded for each participant before the surgical procedure

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 86 participants
• Primary outcome timeframe: preoperative measurement
• Results posted on: 2018-08-28

Participant Flow

Participant milestones

Measure	Bioimpedance Assessment The only group will be those patients having major intra-abdominal surgical procedures. Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period. Bioimpedance Assessment Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period. Bioimpedance Assessment
Overall Study STARTED	86
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Electrical Bioimpedance Assessments to Estimate Perioperative Total Body Water and Postoperative Fluid Need

Baseline characteristics by cohort

Measure	Bioimpedance Assessment n=45 Participants The only group will be those patients having major intra-abdominal surgical procedures. Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period. Bioimpedance Assessment Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period. Bioimpedance Assessment
Age, Continuous	44.5 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: preoperative measurement

Population: This is the population of participants with bioimpedance measurements taken preoperative

Bioimpedance assessment measurements were recorded for each participant before the surgical procedure

Outcome measures

Measure	Bioimpedance Assessment n=45 Participants There are no groups for this study
Bioimpedance Assessment	0.53 ohms Standard Deviation 0.06

PRIMARY outcome

Timeframe: 6 hours postoperative measurement

Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure

Outcome measures

Measure	Bioimpedance Assessment n=45 Participants There are no groups for this study
Bioimpedance Assessment	0.57 ohms Standard Deviation 0.07

PRIMARY outcome

Timeframe: Average measurement, in ohms, taken daily for approximately 8-10 days

Population: This population of participants has their bioimpedance assessment taken daily for approximately 8-10 days postoperative. One average across this time frame was recorded

Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.

Outcome measures

Measure	Bioimpedance Assessment n=45 Participants There are no groups for this study
Bioimpedance Assessment	0.59 ohms Standard Deviation 0.24

SECONDARY outcome

Timeframe: preoperative measurement

Population: This is the final number of participants who met all study eligibility requirements

Extracellular water volume was recorded for each participant before surgical procedure.

Outcome measures

Measure	Bioimpedance Assessment n=45 Participants There are no groups for this study
Percent Extracellular Water Volume	0.89 percent of total water volume Standard Deviation 3.68

SECONDARY outcome

Timeframe: 6 hour postoperative measurement

Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.

Outcome measures

Measure	Bioimpedance Assessment n=45 Participants There are no groups for this study
Percent Intracellular Water Volume	0.82 percent of total water volume Standard Deviation 1.54

SECONDARY outcome

Timeframe: 6 hours postoperative measurement

Population: This population contains data with extracellular water volume measurements taken post-operative

Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.

Outcome measures

Measure	Bioimpedance Assessment n=45 Participants There are no groups for this study
Percent Extracellular Water Volume	0.32 percent of total water volume Standard Deviation 0.34

SECONDARY outcome

Timeframe: Preoperative measurement

Population: This population includes data on participants with recorded intracellular water volume measurements

Intracellular water volume was recorded for each participant before surgical procedure.

Outcome measures

Measure	Bioimpedance Assessment n=45 Participants There are no groups for this study
Percent Intracellular Water Volume	0.30 percent of total water volume Standard Deviation 0.04

SECONDARY outcome

Timeframe: Sum of intakes and outputs each day while inpatient, an average of 8 days

Population: This was the final amount of participants who met all study eligibility requirements

Each participant had a daily calculated fluid balance taken during the course of an approximate 8 day period

Outcome measures

Measure	Bioimpedance Assessment n=45 Participants There are no groups for this study
Daily Fluid Balance (Intakes and Outputs)	1163.1 mL Standard Deviation 1061.8

SECONDARY outcome

Timeframe: preoperative measurement

Population: This population of participants recorded their urine output under preoperative conditions

Overall urine output was collected preoperative

Outcome measures

Measure	Bioimpedance Assessment n=45 Participants There are no groups for this study
Urine Output	406.7 mL Standard Deviation 430.0

SECONDARY outcome

Timeframe: baseline measurement

Population: Baseline BMI was recorded for each participant

Body Mass Index was recorded for each study participant at baseline

Outcome measures

Measure	Bioimpedance Assessment n=45 Participants There are no groups for this study
Study Characteristics of Participants: Body Mass Index	27 kg/m^2 Standard Deviation 5

SECONDARY outcome

Timeframe: preoperative

Population: An ASA classification was recorded for each participant

A classification scale to assess the fitness of patients before surgery

The ASA score is a subjective assessment of a patient's overall physical health. The scale ranges from 1 to 5.

ASA 1 A normal healthy patient. ASA 2 A patient with mild systemic disease. ASA 3 A patient with severe systemic disease. ASA 4 A patient with severe systemic disease that is a constant threat to life. ASA 5 A moribund patient who is not expected to survive

Outcome measures

Measure	Bioimpedance Assessment n=45 Participants There are no groups for this study
American Society of Anaesthesiologists Physical Status Classification Scale	2.2 units on a scale Standard Deviation 0.56

SECONDARY outcome

Timeframe: intraoperative measurement

Population: The population of participants with recorded data on the amount of IV fluids used during surgery

The amount of IV fluids each patient received during the surgical procedure

Outcome measures

Measure	Bioimpedance Assessment n=45 Participants There are no groups for this study
Amount of Intraoperative Fluids	2472.6 mL Standard Deviation 1147.0

Adverse Events

Bioimpedance Assessment

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bioimpedance Assessment n=90 participants at risk The only group will be those patients having major intra-abdominal surgical procedures. Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period. Bioimpedance Assessment Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period. Bioimpedance Assessment
Infections and infestations perineal wound infection	1.1% 1/90 • Number of events 1 • Data collected April 2012 - 13November2014. Adverse event data were collected during that time and occurred between 19Aug2013 and 04Oct2014. At NMCP events are categorized as Adverse Events (AEs) or Serious Adverse Events (SAEs), depending on three criteria: Seriousness, expectedness, and relatedness to the research. An SAE must include all three criteria. SAEs are not limited to physical harms. They may include psychological, societal, and financial harms as well, such as psychological pain and embarrassment, loss of social standing, economic injury, loss of employment, potential for legal action, or loss of insurability, etc.
Respiratory, thoracic and mediastinal disorders Bronchospasm	1.1% 1/90 • Number of events 1 • Data collected April 2012 - 13November2014. Adverse event data were collected during that time and occurred between 19Aug2013 and 04Oct2014. At NMCP events are categorized as Adverse Events (AEs) or Serious Adverse Events (SAEs), depending on three criteria: Seriousness, expectedness, and relatedness to the research. An SAE must include all three criteria. SAEs are not limited to physical harms. They may include psychological, societal, and financial harms as well, such as psychological pain and embarrassment, loss of social standing, economic injury, loss of employment, potential for legal action, or loss of insurability, etc.
Gastrointestinal disorders upper gastrointestinal bleed	1.1% 1/90 • Number of events 1 • Data collected April 2012 - 13November2014. Adverse event data were collected during that time and occurred between 19Aug2013 and 04Oct2014. At NMCP events are categorized as Adverse Events (AEs) or Serious Adverse Events (SAEs), depending on three criteria: Seriousness, expectedness, and relatedness to the research. An SAE must include all three criteria. SAEs are not limited to physical harms. They may include psychological, societal, and financial harms as well, such as psychological pain and embarrassment, loss of social standing, economic injury, loss of employment, potential for legal action, or loss of insurability, etc.

Other adverse events

Measure	Bioimpedance Assessment n=90 participants at risk The only group will be those patients having major intra-abdominal surgical procedures. Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period. Bioimpedance Assessment Bodystat Quadscan 4000: Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period. Bioimpedance Assessment
Vascular disorders Pulmonary embolism	1.1% 1/90 • Number of events 1 • Data collected April 2012 - 13November2014. Adverse event data were collected during that time and occurred between 19Aug2013 and 04Oct2014. At NMCP events are categorized as Adverse Events (AEs) or Serious Adverse Events (SAEs), depending on three criteria: Seriousness, expectedness, and relatedness to the research. An SAE must include all three criteria. SAEs are not limited to physical harms. They may include psychological, societal, and financial harms as well, such as psychological pain and embarrassment, loss of social standing, economic injury, loss of employment, potential for legal action, or loss of insurability, etc.
Blood and lymphatic system disorders hemoperitoneum	1.1% 1/90 • Number of events 1 • Data collected April 2012 - 13November2014. Adverse event data were collected during that time and occurred between 19Aug2013 and 04Oct2014. At NMCP events are categorized as Adverse Events (AEs) or Serious Adverse Events (SAEs), depending on three criteria: Seriousness, expectedness, and relatedness to the research. An SAE must include all three criteria. SAEs are not limited to physical harms. They may include psychological, societal, and financial harms as well, such as psychological pain and embarrassment, loss of social standing, economic injury, loss of employment, potential for legal action, or loss of insurability, etc.
Gastrointestinal disorders pancreatic leak	1.1% 1/90 • Number of events 1 • Data collected April 2012 - 13November2014. Adverse event data were collected during that time and occurred between 19Aug2013 and 04Oct2014. At NMCP events are categorized as Adverse Events (AEs) or Serious Adverse Events (SAEs), depending on three criteria: Seriousness, expectedness, and relatedness to the research. An SAE must include all three criteria. SAEs are not limited to physical harms. They may include psychological, societal, and financial harms as well, such as psychological pain and embarrassment, loss of social standing, economic injury, loss of employment, potential for legal action, or loss of insurability, etc.

Additional Information

Dr. Christopher Oxner

General Surgery, Naval Medical Center Porstmouth

Phone: 757-953-2495

Email: christopher.r.oxner.mil@mail.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place