ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	5 January 2021
Main ID:	ISRCTN81005631
Date of registration:	10/06/2016
Prospective Registration:	No
Primary sponsor:	Pauls Stradinš Clinical University Hospital
Public title:	The evaluation of the potential damage to vascular wall in the perioperative settings during periods of dehydration and following infusion of cristalloid solutions during general anaesthesia
Scientific title:	The relationship between dehydration, fluid volume distribution and damage to the glycocalyx layer during general anaesthesia with sevoflurane and propofol
Date of first enrolment:	01/02/2016
Target sample size:	24
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN81005631
Study type:	Interventional
Study design:	Interventional open label randomised parallel trial (Diagnostic)
Phase:	Not Specified

Countries of recruitment
Latvia

Contacts

Name:	Janis Nemme
Address:	Pauls Stradinš Clinical University Hospital 13 Pilsonu street LV 1002 Riga Latvia
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients scheduled for elective laparotomy under general anesthesia
2. Aged between 20 and 55
3. ASA I-II

Exclusion criteria:
1. Urgent surgery patients
2. ASA III-IV
3. Refusal to participate
4. Pregnancy
5. Those undergoing operations under spinal or epidural anaesthesia
6. Blood loss more than 500 ml
7. Acute or chronic kidney disease

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Perioperative fluid management
Surgery
Perioperative fluid management

Intervention(s)

Participants are randomly allocated to one of two groups using closed envelope randomisation.

Group 1: Anesthesia is gently induced with midazolam, phentanyl, propofol and atracurium without starting iv fluids. Patients are intubated, samples of blood and urine are collected again and immediately fluid load - Ringer Lactate 25 ml/kg in 30 minutes is started. The anesthesia is provided with sevoflurane, phentanyl and atracurium.

Group 2: Anesthesia is gently induced with midazolam, phentanyl, propofol and atracurium without starting iv fluids. Patients are intubated, samples of blood and urine are collected again and immediately fluid load - Ringer Lactate 25 ml/kg in 30 minutes is started. The anesthesia is provided with propofol for 10 minutes at a rate of 10ml/kg/hour, next 10 minutes 8 ml/kg/hour and afterwards - 6-7 ml/kg/hour.

For participants in both groups, further blood samples are taken every 10 minutes till the end of infusion. After the end of infusion 4 blood samples are taken every 5 minutes and afterwards switched back to 10 minutes regimen till the end of anesthesia. Urinary samples are taken every 30 minutes starting from induction of anesthesia. Last samples are taken 2 hours after the end of anesthesia. Every time blood samples has been taken - patients blood pressure and pulse rate is documented.

Primary Outcome(s)

Brain natriuretic peptide (BNP) levels in plasma and urine after rapid fluid infusion are measured using chemiluminescent microparticle immunoassay (CMIA) at baseline (immediately before anaesthesia), immediately after anaesthesia induction, at 30 minute intervals throughout anaesthesia, and two hours after anaesthesia.

Secondary Outcome(s)

1. Changes in glycocalyx shedding products after rapid fluid loading are measured using ELISA at baseline (immediately before anaesthesia), immediately after anaesthesia induction, at 30 minute intervals throughout anaesthesia, and two hours after anaesthesia
2. Capillary leakage is assessed by measuring plasma albumin levels using IL Test Albumin at baseline (immediately before anaesthesia), immediately after anaesthesia induction at 10 minute intervals, every five minutes for 20 minutes after the end of fluid infusion phase, at 10 minutes intervals until the end of anesthesia and two hours after anaesthesia
3. Fluid kinetics of the infused volume of fluids are measured using Haemoglobin (Hgb) levels detected by Coulter HMX methodology at the same frequency as albumin at baseline (immediately before anaesthesia), immediately after anaesthesia induction at 10 minute intervals, every five minutes for 20 minutes after the end of fluid infusion phase, at 10 minutes intervals until the end of anesthesia and two hours after anaesthesia

Secondary ID(s)

R-GS2016

Source(s) of Monetary Support

Pauls Stradinš Clinical University Hospital, Mats Kleberg Foundation

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethics commitee of Pauls Stradinš Clinical University Hospital, 27/01/2016, ref: 270116 - 17L

Results

Results available:	Yes
Date Posted:
Date Completed:	30/06/2018
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.