Fluid Responsiveness in the Postoperative Patient: a Prospective Study

NCT02418663 | Unknown

• 1 other identifier: 14-452 SDR
• Study Type: interventional
• Target: 245
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to determine the prevalence of Fluid Responsiveness (FR) (SV increases by at least 15% after Volume Expansion, VE) in postoperative patients admitted on a surgical ward after elective abdominal, thoracic and esophageal surgery

Conditions

Actual Impaired Fluid Volume

Keywords

fluid responsiveness; enhanced recovery program

Outcome Measures

Primary Outcomes (1)

• FR assessed by the ccNexfin system, anytime VE is ordered by the treating physician

  FR (SV increases by ≥ 15% ) FR will be measured 1 minute after the completion of VE

  For the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery)

Secondary Outcomes (18)

• Prediction of FR

  For the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery)

• FR assessed by the ccNexfin system, at the arrival in PACU and daily on the surgical floor

  At the arrival in PACU and daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery)

• Dynamic Arterial Elastance (absolute number), anytime VE is ordered by the treating physician

  Before the fluid challenge, for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery)

• Heart rate (beat per minute)

  At the arrival in PACU and daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery)

• Arterial Blood Pressure (mmHg)

  At the arrival in PACU and daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery)

Other Outcomes (7)

• Incidence of arterial hypotension, defined as Systolic Blood Pressure less than 90 mmHg or less than 20% of the baseline value

  At the Arrival in PACU and daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery)

• Estimated surgical blood loss

  At the end of surgery

• Amount of volume expansion administered by the treating team

  At the Arrival in PACU and daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery)

Study Arms (1)

Postoperative elective surgical patients

OTHER

Patients undergoing major elective thoracic and abdominal, the latter group including upper gastrointestinal, esophageal, and colorectal procedures. In this group FR will predicted by administering a fluid challenge of 250 ml of Lactated Ringer's solution and measuring SV with the ccNexfin

Drug: Fluid challenge (250 ml Lactated Ringer's solution)

Interventions

Fluid challenge (250 ml Lactated Ringer's solution) DRUG

When VE is prescribed to a patient, a fluid challenge of 250mL Lactated Ringer's solution will first be administered. The ccNexfin system will be used to predict FR (SV increases by at least 15% in response to a fluid challenge). The remaining amount of fluid ordered by the treating team will then be administered, and SV will again be measured. Additionally, a daily fluid challenge with 250mL of Lactated Ringer's will also be administered, with FR recorded as above

Also known as: Lactated Ringer's Injection

Postoperative elective surgical patients

Eligibility Criteria

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

You may qualify if:

• Patients undergoing major elective thoracic and abdominal surgeries, the latter group including upper gastrointestinal, esophageal, and colorectal procedures,
• Patients treated with surgery-specific enhanced recovery programs (ERPs), implemented in 2010 at the Montreal General Hospital for colorectal surgery, and subsequently developed at the same institution for thoracic surgery

You may not qualify if:

• Age \<18 years
• Emergency surgery
• Patients who do not understand, read or communicate in either French or English
• Chronic kidney disease
• Congestive heart failure
• Severe aortic stenosis
• Patients not in sinus rhythm
• Patients requiring fluid restriction for any reason
• Known peripheral vascular disease or Raynaud's phenomenon
• Septic patients
• Acute circulatory shock

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Related Publications (2)

• Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.

  PMID: 9895071 BACKGROUND

• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

  PMID: 3558716 BACKGROUND

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Gabriele Baldini, MD, MSc

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Baldini, MD, MSc

CONTACT

514-934-1934; gabriele.baldini@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: April 16, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 15, 2015

Record last verified: 2015-04