Comparison of the effect of fluid therapy with Ringer and Ringer lactate solution on acid and base status and blood electrolytes in patients with coronary artery bypass graft surgery
The effect of using Ringer and Ringer lactate solutions on acid and base status and blood electrolytes in patients with coronary artery bypass graft surgery
Design
Design:
160 patients who are candidates for coronary artery bypass graft surgery are randomly divided into two groups. This clinical trial will have two parallel groups and one blind one.
Settings and conduct
This study will be performed in the operating room of Shahid Rajaei Cardiovascular Research Center.
Participants/Inclusion and exclusion criteria
Age 30 to 70 years - Weight 30 to 100 kg - No license for severe kidney or liver disease Absence of severe heart failure
Exclusion criteria:
-Cardiac arrest of the patient during surgery or on the first day in the intensive care unit,
-Severe postoperative bleeding on the first day in the intensive care unit
- The patient returns to the pump for any reason
- Intra-aortic implantation of a balloon pump or ECMO
- Transfer of the patient to the ICU with an open sternum
-Need for high-dose inotropes
Intervention groups
After applying the principles of randomization and placing the patient in the intervention group and transferring the patient to the operating room, the necessary monitoring is connected and appropriate intravenous access is established. Is injected. Volume of maintenance fluid per hour according to the law 4ml / kg (initial 10 kg weight) 2ml / kg (second 10 kg weight) 1ml / kg (remaining weight), volume correction due to fasting before the patient's operation, blood volume compensation to be removed And inaccessibility of the vascular system, compensation of urinary out put excess in excess of 1 ml / kg/h during surgery and the first 24 hours of patient admission to the ICU with serum ringer lactate. Primary and secondary outcome variables are measured at desired time points
Main outcome variables
level of blood lactate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161127031131N2
Registration date:2021-11-16, 1400/08/25
Registration timing:registered_while_recruiting
Last update:2021-11-16, 1400/08/25
Update count:0
Registration date
2021-11-16, 1400/08/25
Registrant information
Name
Rasoul Azarfarin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2017
Email address
azarfarin@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of fluid therapy with Ringer and Ringer lactate solution on acid and base status and blood electrolytes in patients with coronary artery bypass graft surgery
Public title
A comparative study of fluid therapy with Ringer's and Ringer's lactate solution on acid and base status and blood electrolytes in patients with coronary artery bypass graft surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age 30 to 70 years - 2.Weight 30 to 100 kg 3. No license for severe kidney or liver disease (creatinine more than 1.5 and liver enzymes more than 2 times normal) 4. Absence of severe heart failure (LVEF> 35%)
Exclusion criteria:
1. Cardiac arrest of the patient during surgery or on the first day in the intensive care unit, 2. Severe postoperative bleeding on the first day (more than 1000 ml) in the intensive care unit 3. The patient returns to the pump for any reason 4. Intra-aortic implantation of a balloon pump or ECMO for any reason 5.Transfer of the patient to the intensive care unit with an open sternum 6. Need for high-dose inotropes (epinephrine or norepinephrine greater than 0.2 micrograms per kilogram of body weight per minute)
Age
From 30 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are randomly assigned to two equal groups and for random assignment, permuted block randomization with quadruple blocks is used.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the patients areunaware of which group they are in, but the patient's caregivers (physician and nurse) and statistical analyst are aware. In this study, after obtaining the patient's consent, it is explained that in one of the two groups, Ringer serum or Ringer lactate serum is and at the time of serum administration in the operating room, the patient is anesthetized and in the intensive care unit, anesthesia of patient continues and is unaware, and after waking up, the name of the serum is covered with the label that the nurse is under. .
1. When the patient enters the operating room 2. After induction of anesthesia 3. Time off from the pump 4.Upon entering the ICU 5.Until the hour after entering the ICU 6.12 hours after entering the ICU 7.18 hours after entering the ICU
Method of measurement
Arterial blood sample and blood gas analyzer
Secondary outcomes
1
Description
level of Sodium,
Timepoint
1. When the patient enters the operating room 2. After induction of anesthesia 3. Time off from the pump 4.Upon entering the ICU 5.Until the hour after entering the ICU 6.12 hours after entering the ICU 7.18 hours after entering the ICU
Method of measurement
Arterial blood sample and blood gas analyzer
2
Description
level of Potasium
Timepoint
1. When the patient enters the operating room 2. After induction of anesthesia 3. Time off from the pump 4.Upon entering the ICU 5.Until the hour after entering the ICU 6.12 hours after entering the ICU 7.18 hours after entering the ICU
Method of measurement
Arterial blood sample and blood gas analyzer
3
Description
Acidose
Timepoint
1. When the patient enters the operating room 2. After induction of anesthesia 3. Time off from the pump 4.Upon entering the ICU 5.Until the hour after entering the ICU 6.12 hours after entering the ICU 7.18 hours after entering the ICU
Method of measurement
Arterial blood sample and blood gas analyzer
4
Description
level of Bicarbonate
Timepoint
1. When the patient enters the operating room 2. After induction of anesthesia 3. Time off from the pump 4.Upon entering the ICU 5.Until the hour after entering the ICU 6.12 hours after entering the ICU 7.18 hours after entering the ICU
Method of measurement
Arterial blood sample and blood gas analyzer
Intervention groups
1
Description
Intervention group: After applying the principles of randomization and placing the patient in the intervention group and transferring the patient to the operating room, the necessary monitoring is connected and appropriate intravenous access is established. Is injected. Volume of maintenance fluid per hour according to the law 4ml / kg (initial 10 kg weight) 2ml / kg (second 10 kg weight) 1ml / kg (remaining weight), volume correction due to fasting before the patient's operation, blood volume compensation to be removed And inaccessibility of the vascular system, compensation of urinary out put excess in excess of 1 ml / kg/h during surgery and the first 24 hours of patient admission to the ICU with serum ringer lactate. Primary and secondary outcome variables are measured at desired time points..
Category
Treatment - Other
2
Description
Control group: In Control group the same volumes of Ringer's solution will be given and the lactate and electrolyte levels measured in same time intervals
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Cardiovascular Research Center
Full name of responsible person
Rasool Azarfarin
Street address
Highway Ayatollah hashemi Rafsanjani Exp, cross Valiasr St