Respiratory Alterations of Acid-base Equilibrium: Acute and Chronic Renal Response
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01540916|
Recruitment Status : Unknown
Verified November 2015 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was: Active, not recruiting
First Posted : February 29, 2012
Last Update Posted : November 10, 2015
Alterations of acid-base equilibrium are very common in critically ill patients. Thus, understanding their pathophysiology and the possible compensatory mechanisms acting in different organs may play an important role in better set the consequent clinical treatment. The lung and the kidney are the two principal actors of such regulations. Although the respiratory response to acid-base alterations is well understood, less information are available for what the renal system is concerned. Such lack of information is partially due to: 1) the historical consideration of the kidney as a "slow" organ, in response to variations in acid-base equilibrium; 2) the lack of a monitoring system to closely assess renal response.
Our group has recently developed a monitoring system aimed at analyzing, in a quasi-continuous and non-invasive manner (every 10 min) the urinary profile in terms of urinary pH and electrolyte concentrations (sodium, potassium, chloride, ammonium).
The investigators hypothesize that the renal system reacts to large as well as to minimal variations of the acid-base equilibrium (especially induced by a variation in the respiratory function) in a very fast way, modifying the urinary concentration (and therefore the urinary excretion) of ammonium and some electrolytes (especially chloride).
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Variations of Acid-base Equilibrium||Other: Increase minute ventilation Other: Decrease minute ventilation||Not Applicable|
To investigate the acute renal response to respiratory alterations of acid-base equilibrium in order to better understand the underlying physiological mechanisms and to evaluate the validity of a renal monitoring system to indirectly assess the effectiveness of the respiratory function.
To collect data on the chronic response of the renal system in patients affected by chronic obstructive pulmonary disease (COPD), as well as on the acute response to acute variation of the chronic respiratory acidosis characterizing patients affected by COPD exacerbation.
Mechanically ventilated patients will undergo controlled variation of the ventilatory setting (hyperventilation vs. hypoventilation) in order to induce a controlled reduction or increase in arterial partial pressure of carbon dioxide (and an increase or reduction of arterial pH), within normal range of pH (7.35 - 7.45) During the variations, urinary concentrations of electrolytes and pH will be monitored.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Respiratory Alterations of Acid-base Equilibrium: Acute and Chronic Renal Response|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||November 2015|
Minute ventilation will be increased of about 30% of baseline value, through an increase in respiratory rate
Other: Increase minute ventilation
Respiratory rate will be increase in order to have a 30% increase of minute ventilation
Minute ventilation will be decreased of about 30% of baseline value, through a decrease in respiratory rate
Other: Decrease minute ventilation
Respiratory rate will be decrease in order to have a 30% decrease of minute ventilation
- Variations in urinary electrolyte concentrations and pH [ Time Frame: From 0 to 4 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540916
|Terapia Intensiva Postoperatoria; Rianimazione Generale - Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico|
|Milan, Italy, 20122|
|Principal Investigator:||Pietro Caironi, MD||Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico|